Notices. Notice of public meeting

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Family Violence Prevention and Services/Grants for Battered Women's Shelters and Related Assistance/Grants to Indian Tribal Organizations (Including Alaska Native Villages) *Program Office:* Administration on Children, Youth, and Families (ACYF), Family and Youth Services Bureau (FYSB). *Program Announcement Number:* HHS-2007-ACF-ACYF-FVPS-0124. *Announcement Title:* Family Violence Prevention and Services/Grants for Battered Women's Shelters and Related Assistance/Grants to Indian Tribal Organizations (including Alaska Native Villages). *CFDA Number:* 93.671. *Due Date for Applications:* February 15, 2007. *Executive Summary:* This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Indian Tribes (including Alaska Native Villages) and Tribal organizations.

The purpose of these grants is to assist Tribes in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year

(FY)2007. Grantees are to be mindful that although the expenditure period for grants is a two-year period, an application is required every year to provide continuity in the provision of services. (See Section II. Award Information, Expenditure Periods.) I. Description *Legislative Authority:* Title III of the Child Abuse Amendments of 1984 (Public Law (Pub. L.) 98-457, 42 United States Code (U.S.C.) 10401 *et seq.* ) is entitled the “Family Violence Prevention and Services Act” (FVPSA). FVPSA was first implemented in FY 1986. The statute was subsequently amended by P.L. 100-294, the “Child Abuse Prevention, Adoptions, and Family Services Act of 1988;” further amended in 1992 by P.L. 102-295; and then amended in 1994 by P.L. 103-322, the “Violent Crime Control and Law Enforcement Act.” FVPSA was amended again in 1996 by P.L. 104-235, the “Child Abuse Prevention and Treatment Act” (CAPTA) of 1996; in 2000 by P.L. 106-386, the “Victims of Trafficking and Violence Protection Act,” and amended further by P.L. 108-36, the “Keeping Children and Families Safe Act of 2003.” FVPSA was most recently amended by P.L. 109-162, the “Violence Against Women Reauthorization Act of 2005” and by P.L. 109-271, which was enacted on August 17, 2006. FVPSA may be found at 42 U.S.C. 10401 *et. seq.* Background The purpose of this legislation is to assist States and Tribes or Tribal organizations in supporting the establishment, maintenance, and expansion of programs and projects to prevent incidents of family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. During FY 2006, the U.S. Department of Health and Human Services

(HHS)made 241 grants to States and Tribes or Tribal organizations. HHS also made 53 family violence prevention grant awards to non-profit State domestic violence coalitions. In addition, HHS supports the Domestic Violence Resource Center Network (DVRN). DVRN consists of the National Resource Center for Domestic Violence

(NRC)and four Special Issue Resource Centers (SIRCs). The four SIRCs are: The Battered Women's Justice Project, the Resource Center on Child Custody and Protection, the Resource Center for the Elimination of Domestic Violence Against Native Women (Sacred Circle), and the Health Resource Center on Domestic Violence. The purpose of NRC and the SIRCs is to provide resource information, training, and technical assistance to Federal, State, and Indian Tribal agencies; local domestic violence prevention programs; and other professionals who provide services to victims of domestic violence. In February, 1996, HHS funded the National Domestic Violence Hotline (Hotline) to ensure that every woman and man has access to information and emergency assistance wherever and whenever it is needed. The Hotline is a 24-hour, toll-free service that provides crisis assistance, counseling, and local shelter referrals to women across the country. Hotline counselors also are available for non-English speaking persons and for people who are hearing-impaired. The Hotline number is 1-800-799-SAFE (7233); the TTY number for the hearing impaired is 1-800-787-3224. General Grant Program Requirements For Tribes or Tribal Organizations Definitions Tribes and Tribal organizations should use the following definitions in carrying out their programs. The definitions are found in section 320 of FVPSA. *Family Violence:* Any act, or threatened act, of violence, including any forceful detention of an individual, which:

(a)Results or threatens to result in physical injury; and

(b)is committed by a person against another individual (including an elderly person) to whom such person is, or was, related by blood or marriage, or otherwise legally related, or with whom such person is, or was, lawfully residing. *Indian Tribe and Tribal organization:* Have the same meanings given such terms in section 450b of Title 25. *Shelter:* The provision of temporary refuge and related assistance in compliance with applicable State law and regulation governing the provision, on a regular basis, of shelter, safe homes, meals, and related assistance to victims of family violence and their dependents. *Related assistance:* The provision of direct assistance to victims of family violence and their dependents for the purpose of preventing further violence, helping such victims to gain access to civil and criminal courts and other community services, facilitating the efforts of such victims to make decisions concerning their lives in the interest of safety, and assisting such victims in healing from the effects of the violence. Related assistance includes:

(a)Prevention services such as outreach and prevention services for victims and their children, assistance to children who witness domestic violence, employment training, parenting, and other educational services for victims and their children, preventive health services within domestic violence programs (including services promoting nutrition, disease prevention, exercise, and prevention of substance abuse), domestic violence prevention programs for school-age children, family violence public awareness campaigns, and violence prevention counseling services to abusers;

(b)Counseling with respect to family violence, counseling or other supportive services provided by peers individually or in groups, and referral to community social services;

(c)Transportation, technical assistance with respect to obtaining financial assistance under Federal and State programs, and referrals for appropriate health-care services (including alcohol and drug abuse treatment), but shall not include reimbursement for any health-care services;

(d)Legal advocacy to provide victims with information and assistance through the civil and criminal courts, and legal assistance; or

(e)Children's counseling and support services, child care services for children who are victims of family violence or the dependents of such victims, and children who witness domestic violence. The Importance of Coordination of Services The affect of domestic violence includes physical injury and death of primary or secondary victims, psychological trauma, isolation from family and friends, harm to children witnessing or experiencing violence in homes in which the violence occurs, increased fear, reduced mobility and employability, homelessness, substance abuse, and a host of other health and related mental health consequences. The physical and cultural obstacles existing in much of Indian country compound the basic dynamics of domestic violence. Barriers such as the isolation of vast rural areas, the concern for safety in isolated settings, and the transportation requirements over long distances, heighten the need for the coordination of the services through an often limited delivery system. In a project intended to broaden the reach of the Indian Tribal domestic violence communities, the Indian Health Service

(IHS)and FVPSA-funded programs have collaborated to oversee the development of domestic violence community projects. These projects are designed to develop improved health care responses to domestic violence and to facilitate collaboration between the local health care system and local Indian Tribal domestic violence advocacy programs (including Alaskan Village programs). In this effort, IHS also is collaborating with representatives of Mending the Sacred Hoop, Cangleska, Inc., and the Family Violence Prevention Fund to provide training, technical assistance, and oversight to the pilot projects. To help bring about a more effective response to the problem of domestic violence, HHS urges Tribes and Tribal organizations receiving funds under this grant announcement to coordinate activities under this grant with other new and existing resources for the prevention of domestic violence. Annual Tribal Grantee Conference FVPSA administrators should plan to attend the annual Tribal Grantee Conference. A subsequent Program Instruction and/or Information Memorandum will advise the Tribal FVPSA Administrators of the date, time, and location of the grantee conference. Client Confidentiality FVPSA programs must establish or implement policies and protocols for maintaining the safety and confidentiality of the victims of domestic violence, sexual assault, and stalking. It is essential that the confidentiality of adult victims and their children receiving FVPSA services be protected. Consequently, when providing statistical data on program activities, individual identifiers of client records will not be used (section 303(a)(2)(E)). II. Funds Available For FY 2007, HHS will make available for grants to designated State agencies 70 percent of the amount appropriated under section 310(a)(1) of the FVPSA, which is not reserved under section 310(a)(2). In this separate announcement, HHS will allocate 10 percent of the foregoing appropriation to Tribes and Tribal organizations for the establishment and operation of shelters, safe houses, and the provision of related services. HHS also plans to make 10 percent of the foregoing appropriation available to State domestic violence coalitions to continue their work within the domestic violence community by providing technical assistance and training and advocacy services, among other activities, to local domestic violence programs to encourage appropriate responses to domestic violence within the States. Five percent of the amount appropriated under section 310(a)(1) of the FVPSA, which is not reserved under section 310(a)(2), will be available in FY 2007 to continue the support for the NRC and the four SIRCs. Additional funds appropriated under FVPSA will be used to support other activities, including training and technical assistance, collaborative projects with advocacy organizations and service providers, data collection efforts, public education activities, research and other demonstration projects, as well as the ongoing operation of the Hotline. Native American Tribal Allocations Native American Tribes and Tribal organizations are eligible for funding under this program if they meet the definition of “Indian Tribe” or “Tribal organization” at 25 U.S.C. 450b, and if they are able to demonstrate their capacity to carry out family violence prevention and services programs. Any Tribe that believes it meets the eligibility criteria should provide supportive documentation in its application and a request for inclusion on the list of eligible Tribes. (See Section IV. Application Requirements for Tribes or Tribal Organizations.) In computing Tribal allocations, ACF will use the latest available population figures from the Census Bureau. If Census Bureau data are unavailable, ACF will use figures from the Bureau of Indian Affairs' (BIA's) Indian Population and Labor Force Report. Because section 304 of FVPSA specifies a minimum base amount for State allocations, ACF has set a base amount for Tribal allocations. Since FY 1986, it has been, in practice, that the establishment of a base amount has facilitated ACF's efforts to make a fair and equitable distribution of limited grant funds. Due to the expanded interest in the prevention of domestic violence and in the provision of services to victims of family violence and their dependents, an increasing number of Tribal applications have been received over the past several years. In order to ensure the continuance of an equitable distribution of family violence prevention and services funding in response to the increased number of Tribes that apply, the funding formula for the allocation of family violence funds has been adjusted. Tribes that meet the application requirements and whose reservation and surrounding Tribal Trust Lands' population is: • Less than or equal to 1,500 will receive a minimum base amount of $1,500; • Between 1,501 and 3,000 will receive a minimum base amount of $3,000; • Between 3,001 and 4,000 will receive a minimum base amount of $4,000; and, • Between 4,001 and 5,000 will receive a minimum base amount of $5,000. The minimum base amounts are computed in relation to the Tribe's population and the progression of an additional $1,000 per 1,000 persons if the population range continues until the Tribe's population reaches 50,000. Tribes with a population of 50,000 to l00,000 will receive a minimum of $50,000, and Tribes with a population of 100,001 to 150,000 will receive a minimum of $100,000. Once the base amounts have been distributed to the Tribes that have applied for FVPSA funding, the ratio of the Tribe's population to the total population of all the applicant Tribes is then considered in allocating the remainder of the funds. ACF has accounted for the variance in actual population and scope of the FVPSA programs with the distribution of a proportional amount plus a base amount to the Tribes. Under the previous allocation plan, ACF did not have a method by which to consider the variance in Tribal census counts. As in previous years, Tribes are encouraged to apply as consortia for the FVPSA funding. Expenditure Periods FVPSA funds may be used for expenditures on and after October 1 of each fiscal year for which they are granted, and will be available for expenditure through September 30 of the following fiscal year, i.e., FY 2007 funds may be used for expenditures from October 1, 2006 through September 30, 2008. Funds are available for obligation through September 30, 2008 and must be liquidated by September 30, 2009. Re-allotted funds, if any, are available for expenditure until the end of the fiscal year following the fiscal year that the funds became available for re-allotment. FY 2007 grant funds that are made available to Tribes and Tribal organizations through reallotment must be expended by the grantee no later than September 30, 2008. III. Eligibility Tribes and Tribal organizations are eligible for funding under this program if they meet the definition of “Indian Tribe” or “Tribal organization” set forth in section 450B of Title 25 and if they are able to demonstrate their capacity to carry out a family violence prevention and services program. Any Tribe or Tribal organization that believes it meets the eligibility criteria and should be included in the list of eligible Tribes should provide supportive documentation and a request for inclusion in its application. (See Application Content Requirements below.) As in previous years, Tribes may apply singularly or as a consortium. In addition, a non-profit private organization, approved by a Tribe for the operation of a family violence shelter or program on a reservation is eligible for funding. Additional Information on Eligibility D-U-N-S Requirement All applicants must have a D&B Data Universal Numbering System (D-U-N-S) number. On June 27, 2003, the Office of Management and Budget

(OMB)published in the **Federal Register** a new Federal policy applicable to all Federal grant applicants. The policy requires Federal grant applicants to provide a D-U-N-S number when applying for Federal grants or cooperative agreements on or after October 1, 2003. The D-U-N-S number will be required whether an applicant is submitting a paper application or using the government-wide electronic portal, *Grants.gov.* A D-U-N-S number will be required for every application for a new award or renewal/continuation of an award, including applications or plans under formula, entitlement, and block grant programs, submitted on or after October 1, 2003. Please ensure that the applicant has a D-U-N-S number. To acquire a D-U-N-S number at no cost, call the dedicated toll-free D-U-N-S number request line at 1-866-705-5711 or request a number online at *http://www.dnb.com.* IV. Application Requirements for Tribes and Tribal Organizations The Paperwork Reduction Act of 1995 (Pub. L. 104-13) Public reporting burden for this collection of information is estimated to average six hours per response, including the time for reviewing instructions, gathering and maintaining the data needed, and reviewing the collection information. The project description is approved under the Office of Management and Budget

(OMB)control number 0970-0280, which expires October 31, 2008. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Form and Content of Application Submission The application from the Tribe or Tribal organization must be signed by the Chief Executive Officer or Tribal Chairperson of the applicant organization. Each application must contain the following information or documentation: 1. The name of the organization or agency and the Chief Program Official designated as responsible for administering funds under FVPSA and coordinating related programs, and the name, telephone number, and fax number, if available, of a contact person in the designated organization or agency. 2. A copy of a current resolution stating that the designated organization or agency has the authority to submit an application on behalf of the individuals in the Tribe(s) and to administer programs and activities funded under this program (section 303(b)(2)). 3. A description of the procedures designed to involve knowledgeable individuals and interested organizations in providing services under FVPSA (section 303(b)(2)). For example, knowledgeable individuals and interested organizations may include: Tribal officials or social services staff involved in child abuse or family violence prevention, Tribal law enforcement officials, representatives of State coalitions against domestic violence, and operators of family violence shelters and service programs. 4. A description of the applicant's operation of, and/or capacity to carry out, a family violence prevention and services program. This might be demonstrated in ways such as the following:

(a)The current operation of a shelter, safe house, or family violence prevention program;

(b)The establishment of joint or collaborative service agreements with a local public agency or a private non-profit agency for the operation of family violence prevention activities or services; or

(c)The operation of social services programs as evidenced by receipt of “638” contracts with BIA; Title II Indian Child Welfare grants from BIA; Child Welfare Services grants under Title IV-B of the Social Security Act; or Family Preservation and Family Support grants under title IV-B of the Social Security Act. 5. A description of the services to be provided, how the applicant organization plans to use the grant funds to provide the direct services, to whom the services will be provided, and the expected results of the services. 6. Documentation of the procedures that assure the confidentiality of records pertaining to any individual who has been provided family violence prevention or treatment services by any program assisted under FVPSA (section 303(b)(2)). 7. The Employee Identification Number

(EIN)of the applicant organization submitting the application. Assurances Each application must contain the following assurances:

(a)That not less than 70 percent of the funds shall be used for immediate shelter and related assistance for victims of family violence and their dependents and not less than 25 percent of the funds distributed shall be used to provide related assistance (section 303(g)).

(b)That any grants made to an entity other than a State or Tribe will meet the matching requirements in section 303(f), i.e., not less than 20 percent of the total funds provided for a project under Chapter 110 of Title 42 of the U.S. Code with respect to an existing program, and with respect to an entity intending to operate a new program under this title, not less than 35 percent. The local share will be cash or in-kind; and the local share will not include any Federal funds provided under any authority other than this chapter (section 303(f)).

(c)That grant funds made available under FVPSA will not be used as direct payment to any victim or dependent of a victim of family violence (section 303(d)).

(d)That no income eligibility standard will be imposed on individuals receiving assistance or services supported with funds appropriated to carry out FVPSA (section 303(e)).

(e)That the address or location of any shelter or facility assisted under FVPSA will not be made public, except with the written authorization of the person or persons responsible for the operations of such shelter (section 303(a)(2)(E)).

(f)That a law or procedure has been implemented for the eviction of an abusing spouse from a shared household (section 303(a)(2)(F)).

(g)That all grants, programs or other activities funded by the State in whole or in part with funds made available under FVPSA will prohibit discrimination on the basis of age, handicap, sex, race, color, national origin or religion (section 307).

(h)That the applicant will comply with the applicable Departmental recordkeeping and reporting requirements and general requirements for the administration of grants under 45 CFR Part 92. Certifications All applications must submit or comply with the required certifications found in the Appendices as follows: *Anti-Lobbying Certification and Disclosure Form (See Appendix A):* Applicants who have used non-Federal funds for lobbying activities in connection with receiving assistance under this announcement shall complete a disclosure form, if applicable, with their applications (approved by OMB under control number 0348-0046). Applicants should sign and return the certification with their application. *Certification Regarding Environmental Tobacco Smoke (See Appendix B):* Applicants must also understand they will be held accountable for the smoking prohibition included within P.L. 103-227, Title XII Environmental Tobacco Smoke (also known as the Pro-Children Act of 1994). A copy of the **Federal Register** notice, which implements the smoking prohibition is included with the forms. By signing and submitting the application, applicants are providing the certification and need not mail back the certification with the application. *Certification Regarding Drug-Free Workplace Requirements (See Appendix C):* The signature on the application by the chief program official attests to the applicant's intent to comply with the Drug-Free Workplace requirements and compliance with the Debarment Certification. The Drug-Free Workplace certification does not have to be returned with the application. These certifications also may be found at *http://www.acf.hhs.gov/programs/ofs/forms.htm* . Notification Under Executive Order 12372 The review and comment provisions of the Executive Order (E.O.) and Part 100 do not apply. Federally recognized Tribes are exempt from all provisions and requirements of E.O. 12372. Applications should be sent to: Family Violence Prevention and Services Program, Family and Youth Services Bureau, Administration on Children, Youth, and Families, Administration for Children and Families, Attention: William D. Riley, 1250 Maryland Avenue, SW., Room 8402, Washington, DC 20024. V. Approval/Disapproval of a Tribal or Tribal Organization Application The Secretary of HHS will approve any application that meets the requirements of FVPSA and this announcement. The Secretary will not disapprove an application except after reasonable notice of the Secretary's intention to disapprove has been provided to the applicant and after a six-month period providing an opportunity for the applicant to correct any deficiencies. The notice of intention to disapprove will be provided to the applicant within 45 days of the date of the application. VI. Reporting Requirements Performance Reports A performance report must be filed with HHS describing the activities carried out, and including an assessment of the effectiveness of those activities in achieving the purposes of the grant. A section of this performance report must be completed by each grantee or sub-grantee that performed the direct services contemplated in the application certifying performance of such services. Consortia grantees should compile performance reports into a comprehensive report for submission. *The Performance Report should include the following data elements:* *Funding* —The total amount of the FVPSA grant funds awarded; the percentage of funding used for shelters, and the percentage of funding used for related assistance and services. *Shelters* —The number of shelters and shelter programs (safe homes/motels, etc.) assisted by FVPSA program funding. Data elements should include: • The number of shelters • The number of women sheltered • The number of young children sheltered (birth-12 years of age) • The number of teenagers and young adults sheltered (13-17 years of age) • The number of men sheltered • The average length of stay • The number of women, children, teens, and others who were turned away because shelter was unavailable • The number of women, children, teens, and others who were referred to other shelters due to lack of space *Types of individuals served* —Record information by numbers and percentages of the total population served. Individuals and special populations served should include: • The elderly • Individuals with physical challenges *Related assistance and services* —List the types of related assistance and services provided to victims and their family members by indicating the number of women, children, and men who have received services. Services and assistance may include, but are not limited to, the following: • Individual counseling • Services to children • Crisis intervention hotline • Information and referral • Batterers' support services • Legal advocacy services • Transportation • Services to teenagers • Emergency child care • Training and technical assistance • Housing advocacy *Volunteers* —List the total number of volunteers and hours worked. *Service referrals* —List the number of women, children, and men referred for the following services: • Physical abuse • Alcohol abuse • Drug abuse • Batterer intervention services • Child abuse • Witnessed abuse • Emergency medical intervention • Law enforcement intervention The performance report should include narratives of success stories about services provided and the positive impact on the lives of children and families. Examples may include the following: • An explanation of the activities carried out, including an assessment of the major activities supported by the family violence funds; what particular priorities within the Tribe or Tribal organization were addressed; and what special emphases were placed on these activities; A description of the specific services and facilities that the applicant program funded, contracted with, or otherwise used in the implementation of its program, *e.g.* , shelters, safe houses, related assistance, programs for batterers; • An assessment of the effectiveness of the direct service activities contemplated in the application; • A description of how the needs of under-served populations, including those persons geographically isolated, were addressed; and • A description and assessment of the prevention activities supported during the program year, *e.g.* , community education events, and public awareness efforts. Performance reports for Tribes and Tribal organizations are due at the end of every calendar year (December 29). Performance reports should be sent to: Family Violence Prevention and Services Program, Family and Youth Services Bureau, Administration on Children, Youth and Families, Administration for Children and Families, Attn: William Riley, 1250 Maryland Avenue, SW., Room 8402, Washington, DC 20024. Financial Status Reports Grantees must submit annual Financial Status Reports. The first SF-269A is due December 29, 2007. It covers expenditures from date of award through September 30, 2007. The interim SF-269A is due December 29, 2008. The final SF-269A is due December 29, 2009. SF-269A can be found at: *http://www.whitehouse.gov/omb/grants/grantsforms.html.* Completed reports may be mailed to: Rachel Hickson, Division of Mandatory Grants, Office of Grants Management, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447. Grantees have the option of submitting their reports online through the Online Data Collection

(OLDC)system at the following address: *https://extranet.acf.hhs.gov/ssi/.* The Division of Mandatory Grants can assist grantees with access to OLDC. Failure to submit reports on time may be a basis for withholding grant funds, suspension, or termination of the grant. In addition, all funds reported after the obligation period will be recouped. VII. Administrative and National Policy Requirements Tribes and Tribal Organizations will comply with the applicable Departmental recordkeeping and reporting requirements and general requirements for the administration of grants under 45 CFR part 92. Direct Federal grants, sub-award funds, or contracts under this ACF program shall not be used to support inherently religious activities such as religious instruction, worship, or proselytization. Therefore, organizations must take steps to separate, in time or location, their inherently religious activities from the services funded under this program. Regulations pertaining to Equal Treatment for Faith-Based Organizations, which includes the prohibition against Federal funding of inherently religious activities, can be found at the HHS Web site at *http://www.hhs.gov/fbci/regs.html.* Faith-based and community organizations may reference the “Guidance to Faith-Based and Community Organizations on Partnering with the Federal Government” at *http://www.whitehouse.gov/government/fbci/guidance/index.html.* VIII. Other Information *For Further Information Contact:* Shena Williams at

(202)205-9532 or e-mail at *swilliams1@acf.hhs.gov;* William D. Riley at

(202)401-5529 or e-mail at *wriley@acf.hhs.gov;* or Millicent Crawford at

(202)205-7746 or e-mail at *mcrawford@acf.hhs.gov.* Dated: January 4, 2007. Joan E. Ohl, Commissioner, Administration on Children, Youth, and Families. Appendices: Required Certifications A. Certification Regarding Lobbying B. Certification Regarding Environmental Tobacco Smoke C. Drug-Free Workplace Requirements Appendix A—Certification Regarding Lobbying Certification for Contracts, Grants, Loans, and Cooperative Agreements The undersigned certifies, to the best of his or her knowledge and belief, that:

(1)No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.

(2)If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions.

(3)The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Statement for Loan Guarantees and Loan Insurance The undersigned states, to the best of his or her knowledge and belief, that: If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this commitment providing for the United States to insure or guarantee a loan, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions. Submission of this statement is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Signature Title Organization Appendix B—Certification Regarding Environmental Tobacco Smoke Public Law 103-227, Part C Environmental Tobacco Smoke, also known as the Pro Children Act of 1994 (Act), requires that smoking not be permitted in any portion of any indoor routinely owned or leased or contracted for by an entity and used routinely or regularly for provision of health, day care, education, or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law does not apply to children's services provided in private residences, facilities funded solely by Medicare or Medicaid funds, and portions of facilities used for inpatient drug or alcohol treatment. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1000 per day and/or the imposition of an administrative compliance order on the responsible entity. By signing and submitting this application the applicant/grantee certifies that it will comply with the requirements of the Act. The applicant/grantee further agrees that it will require the language of this certification be included in any subawards which contain provisions for the children's services and that all subgrantees shall certify accordingly. Appendix C—Certification Regarding Drug-Free Workplace Requirements This certification is required by the regulations implementing the Drug-Free Workplace Act of 1988: 45 CFR Part 76, Subpart, F. Sections 76.630(c) and (d)(2) and 76.645(a)(1) and

(b)provide that a Federal agency may designate a central receipt point for STATE-WIDE AND STATE AGENCY-WIDE certifications, and for notification of criminal drug convictions. For the Department of Health and Human Services, the central point is: Division of Grants Management and Oversight, Office of Management and Acquisition, Department of Health and Human Services, Room 517-D, 200 Independence Avenue, SW., Washington, DC 20201. Certification Regarding Drug-Free Workplace Requirements (Instructions for Certification) 1. By signing and/or submitting this application or grant agreement, the grantee is providing the certification set out below. 2. The certification set out below is a material representation of fact upon which reliance is placed when the agency awards the grant. If it is later determined that the grantee knowingly rendered a false certification, or otherwise violates the requirements of the Drug-Free Workplace Act, the agency, in addition to any other remedies available to the Federal Government, may take action authorized under the Drug-Free Workplace Act. 3. For grantees other than individuals, Alternate I applies. 4. For grantees who are individuals, Alternate II applies. 5. Workplaces under grants, for grantees other than individuals, need not be identified on the certification. If known, they may be identified in the grant application. If the grantee does not identify the workplaces at the time of application, or upon award, if there is no application, the grantee must keep the identity of the workplace(s) on file in its office and make the information available for Federal inspection. Failure to identify all known workplaces constitutes a violation of the grantee's drug-free workplace requirements. 6. Workplace identifications must include the actual address of buildings (or parts of buildings) or other sites where work under the grant takes place. Categorical descriptions may be used (e.g., all vehicles of a mass transit authority or State highway department while in operation, State employees in each local unemployment office, performers in concert halls or radio studios). 7. If the workplace identified to the agency changes during the performance of the grant, the grantee shall inform the agency of the change(s), if it previously identified the workplaces in question (see paragraph five). 8. Definitions of terms in the Nonprocurement Suspension and Debarment common rule and Drug-Free Workplace common rule apply to this certification. Grantees' attention is called, in particular, to the following definitions from these rules: *Controlled substance* means a controlled substance in Schedules I through V of the Controlled Substances Act (21 U.S.C. 812) and as further defined by regulation (21 CFR 1308.11 through 1308.15); *Conviction* means a finding of guilt (including a plea of nolo contendere) or imposition of sentence, or both, by any judicial body charged with the responsibility to determine violations of the Federal or State criminal drug statutes; *Criminal drug statute* means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, use, or possession of any controlled substance; *Employee* means the employee of a grantee directly engaged in the performance of work under a grant, including:

(i)All direct charge employees;

(ii)All indirect charge employees unless their impact or involvement is insignificant to the performance of the grant; and,

(iii)Temporary personnel and consultants who are directly engaged in the performance of work under the grant and who are on the grantee's payroll. This definition does not include workers not on the payroll of the grantee ( *e.g.* , volunteers, even if used to meet a matching requirement; consultants or independent contractors not on the grantee's payroll; or employees of subrecipients or subcontractors in covered workplaces). Certification Regarding Drug-Free Workplace Requirements Alternate I. (Grantees Other Than Individuals) The grantee certifies that it will or will continue to provide a drug-free workplace by:

(a)Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession, or use of a controlled substance is prohibited in the grantee's workplace and specifying the actions that will be taken against employees for violation of such prohibition;

(b)Establishing an ongoing drug-free awareness program to inform employees about—

(1)The dangers of drug abuse in the workplace;

(2)The grantee's policy of maintaining a drug-free workplace;

(3)Any available drug counseling, rehabilitation, and employee assistance programs; and

(4)The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(c)Making it a requirement that each employee to be engaged in the performance of the grant be given a copy of the statement required by paragraph (a);

(d)Notifying the employee in the statement required by paragraph

(a)that, as a condition of employment under the grant, the employee will—

(1)Abide by the terms of the statement; and

(2)Notify the employer in writing of his or her conviction for a violation of a criminal drug statute occurring in the workplace no later than five calendar days after such conviction;

(e)Notifying the agency in writing, within 10 calendar days after receiving notice under paragraph (d)(2) from an employee or otherwise receiving actual notice of such conviction. Employers of convicted employees must provide notice, including position title, to every grant officer or other designee on whose grant activity the convicted employee was working, unless the Federal agency has designated a central point for the receipt of such notices. Notice shall include the identification number(s) of each affected grant;

(f)Taking one of the following actions, within 30 calendar days of receiving notice under paragraph (d)(2), with respect to any employee who is so convicted—

(1)Taking appropriate personnel action against such an employee, up to and including termination, consistent with the requirements of the Rehabilitation Act of 1973, as amended; or

(2)Requiring such employee to participate satisfactorily in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health, law enforcement, or other appropriate agency;

(g)Making a good faith effort to continue to maintain a drug-free workplace through implementation of paragraphs (a), (b), (c), (d),

(e)and (f).

(B)The grantee may insert in the space provided below the site(s) for the performance of work done in connection with the specific grant: Place of Performance (Street address, city, county, state, zip code) Check if there are workplaces on file that are not identified here. Alternate II. (Grantees Who Are Individuals)

(a)The grantee certifies that, as a condition of the grant, he or she will not engage in the unlawful manufacture, distribution, dispensing, possession, or use of a controlled substance in conducting any activity with the grant;

(b)If convicted of a criminal drug offense resulting from a violation occurring during the conduct of any grant activity, he or she will report the conviction, in writing, within 10 calendar days of the conviction, to every grant officer or other designee, unless the Federal agency designates a central point for the receipt of such notices. When notice is made to such a central point, it shall include the identification number(s) of each affected grant. [FR Doc. E7-372 Filed 1-12-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Family Violence Prevention and Services/Grants for Battered Women's Shelters/Grants to States *Program Office:* Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB). *Program Announcement Number:* HHS-2007-ACF-ACYF-FVPS-0123. *Announcement Title:* Family Violence Prevention and Services/Grants for Battered Women's Shelters/Grants to States. *CFDA Number:* 93.671. *Due Date for Applications:* February 15, 2007. *Executive Summary:* This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including Territories and Insular Areas). The purpose of these grants is to assist States in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year

(FY)2007. I. Description *Legislative Authority:* Title III of the Child Abuse Amendments of 1984 (Public Law (Pub. L.) 98-457, 42 United States Code (U.S.C.) 10401 *et seq.* ) is entitled the “Family Violence Prevention and Services Act” (FVPSA). FVPSA was first implemented in FY 1986. The statute was subsequently amended by Pub. L. 100-294, the “Child Abuse Prevention, Adoptions, and Family Services Act of 1988;” further amended in 1992 by Pub. L. 102-295; and then amended in 1994 by Pub. L. 103-322, the “Violent Crime Control and Law Enforcement Act.” FVPSA was amended again in 1996 by Pub. L. 104-235, the “Child Abuse Prevention and Treatment Act (CAPTA) of 1996;” in 2000 by Pub. L. 106-386, the “Victims of Trafficking and Violence Protection Act,” and amended further by Pub. L. 108-36, the “Keeping Children and Families Safe Act of 2003.” FVPSA was most recently amended by Pub. L. 109-162, the “Violence Against Women Reauthorization Act of 2005” and by Pub. L. 109-271, which was enacted on August 17, 2006.” FVPSA may be found at 42 U.S.C. 10401 *et seq.* Background The purpose of this legislation is to assist States and Indian Tribes, Tribal organizations, and non-profit private organizations approved by an Indian Tribe in supporting the establishment, maintenance, and expansion of programs and projects to prevent incidents of family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. During FY 2006, 241 grants were made to States and Indian Tribes, Tribal organizations, and non-profit private organizations approved by Indian Tribes. The U.S. Department of Health and Human Services

(HHS)also made 53 family violence prevention grant U.S. awards to non-profit State domestic violence coalitions. In addition, HHS supports the National Resource Center for Domestic Violence

(NRC)and four Special Issue Resource Centers (SIRCs). The four SIRCs are the Battered Women's Justice Project, the Resource Center on Child Custody and Protection, Sacred Circle Resource Center for the Elimination of Domestic Violence Against Native Women, and the Health Resource Center on Domestic Violence. The purpose of NRC and SIRCs is to provide resource information, training, and technical assistance to Federal, State, and Native American agencies, local domestic violence prevention programs, and other professionals who provide services to victims of domestic violence. In February 1996, HHS funded the National Domestic Violence Hotline (Hotline) to ensure that every woman and man has access to information and emergency assistance wherever and whenever it is needed. The Hotline is a 24-hour, toll-free service that provides crisis assistance, counseling, and local shelter referrals to women across the country. Hotline counselors also are available for non-English speaking persons and for people who are hearing-impaired. The Hotline number is 1-800-799-SAFE (7233); the TTY number for the hearing-impaired is 1-800-787-3224. General Grant Program Requirements Applicable to States Definitions States should use the following definitions in carrying out their programs. The definitions are found in section 320 of FVPSA. *Family Violence:* Any act or threatened act of violence, including any forceful detention of an individual, which:

(a)Results or threatens to result in physical injury; and

(b)is committed by a person against another individual (including an elderly person) to whom such person is or was related by blood or marriage or otherwise legally related or with whom such person is or was lawfully residing. *Shelter:* The provision of temporary refuge and related assistance in compliance with applicable State law and regulation governing the provision, on a regular basis, of shelter, safe homes, meals, and related assistance to victims of family violence and their dependents. *Related assistance:* The provision of direct assistance to victims of family violence and their dependents for the purpose of preventing further violence, helping such victims to gain access to civil and criminal courts and other community services, facilitating the efforts of such victims to make decisions concerning their lives in the interest of safety, and assisting such victims in healing from the effects of the violence. Related assistance includes:

(a)Prevention services such as outreach and prevention services for victims and their children, assistance for children who witness domestic violence, employment training, parenting and other educational services for victims and their children, preventive health services within domestic violence programs (including services promoting nutrition, disease prevention, exercise, and prevention of substance abuse), domestic violence prevention programs for school-age children, family violence public awareness campaigns, and violence prevention counseling services to abusers;

(b)Counseling with respect to family violence, counseling or other supportive services provided by peers individually or in groups, and referral to community social services;

(c)Transportation and technical assistance with respect to obtaining financial assistance under Federal and State programs, and referrals for appropriate health-care services (including alcohol and drug abuse treatment), but shall not include reimbursement for any health-care services;

(d)Legal advocacy to provide victims with information and assistance through the civil and criminal courts, and legal assistance; or

(e)Children's counseling and support services, and child care services for children who are victims of family violence or the dependents of such victims, and children who witness domestic violence. Annual State Administrators Grantee Conference The annual grantee conference for the State FVPSA Administrators is a training and technical assistance activity. A subsequent Program Instruction and/or Information Memorandum will advise the State FVPSA Administrators of the date, time and location of their grantee conference. Client Confidentiality FVPSA programs must establish or implement policies and protocols for maintaining the safety and confidentiality of the adult victims and their children of domestic violence, sexual assault, and stalking. It is essential that the confidentiality of individuals receiving FVPSA services be protected. Consequently, when providing statistical data on program activities and program services, individual identifiers of client records will not be used (section 303(a)(2)(E)). The confidentiality provisions described at 42 U.S.C., section 13701, apply to programs funded under the Violence Against Women Act, as amended, including certain awards made under the Family Violence Prevention and Services Act. These confidentiality requirements were strengthened and clarified with the passage of the Violence Against Women Reauthorization Act of 2005, Pub. L. 109-162, as recently amended by Pub. L. 109-271. The revised confidentiality provisions impose conditions regarding the disclosure of personally identifying information, confidentiality, information sharing, and compulsory release of information. Stop Family Violence Postal Stamp The U.S. Postal Service was directed by the “Stamp Out Domestic Violence Act of 2001” (the Act), Pub. L. 107-62, to make available a “semipostal” stamp to provide funding for domestic violence programs. Funds raised in connection with sales of the stamp, less reasonable costs, have been transferred to HHS in accordance with the Act for support of services to children and youth affected by domestic violence. As of FY 2006, $2.3 million has been transferred and made available in support of grants for “Demonstration Programs for The Enhanced Services to Children and Youth Who Have Been Exposed to Domestic Violence.” Sixty-five

(65)applications were received and reviewed and nine

(9)successful applicants are in the second year of their projects. The project sites are in Castle Rock, CO; Harrisburg, PA; Oklahoma City, OK; Eugene, OR; Oakland, CA; Albany, NY; Lansing, MI; Richmond, VA; and Washington, DC. ACF anticipates information on the progress and activities of the successful applicants and their programs in FY 2007. The Importance of Coordination of Services The impacts of domestic violence include physical injury and death of primary or secondary victims, psychological trauma, isolation from family and friends, harm to children witnessing or experiencing violence in homes in which the violence occurs, increased fear, reduced mobility and employability, homelessness, substance abuse, and a host of other health and related mental health consequences. Coordination and collaboration among the police, prosecutors, the courts, victim services providers, child welfare and family preservation services, and medical and mental health service providers is needed to provide more responsive and effective services to victims of domestic violence and their families. It is essential that all interested parties are involved in the design and improvement of intervention and prevention activities. To help bring about a more effective response to the problem of domestic violence, HHS urges the designated State agencies receiving funds under this grant announcement to coordinate activities funded under this grant with other new and existing resources for the prevention of domestic violence and related issues. National Data Collection and Outcomes Measurement

(DOW)The need to accurately communicate reliable and appropriate data that capture the impact of domestic violence prevention and intervention efforts, and to provide shelters, States and State domestic violence coalitions with tools for self-assessment, continues as the Documenting Our Work

(DOW)Initiative. In collaboration with partners at the State FVPSA programs, State domestic violence coalitions, and experts on both data collection and domestic violence prevention issues, the effort to develop informative, succinct and non-burdensome reporting formats continues. During FY 2006 and in concert with State FVPSA administrators, State domestic violence coalitions, and local service providers, four

(4)States have volunteered as pilot sites to assess proposed program reporting procedures and test the reliability of the outcome measures for FVPSA programs. Any recommended changes for information and reporting formats will be accompanied by specifically designated workshops or adjunctive discussions to regularly occurring meetings. II. Funds Available For FY 2007, HHS will make available for grants to designated State agencies 70 percent of the amount appropriated under section 310(a)(1) of FVPSA, which is not reserved under section 310(a)(2). In separate announcements, HHS will allocate 10 percent of the foregoing appropriation to Tribes and Tribal organizations for the establishment and operation of shelters, safe houses, and the provision of related services; and 10 percent to the State Domestic Violence Coalitions to continue their work within the domestic violence community by providing technical assistance and training, and advocacy services among other activities with local domestic violence programs and to encourage appropriate responses to domestic violence within the States. Five percent of the amount appropriated under section 310(a)(1) of FVSPA, which is not reserved under section 310(a)(2), will be available in FY 2007 to continue the support for the NRC and the four SIRCs. Additional funds appropriated under FVPSA will be used to support other activities, including training and technical assistance, collaborative projects with advocacy organizations and service providers, data collection efforts, public education activities, research and other demonstration projects, as well as the ongoing operation of the Hotline. State Allocation FVPSA grants to the States, the District of Columbia, and the Commonwealth of Puerto Rico are based on a population formula. Each State grant shall be $600,000 with the remaining funds allotted to each State on the same ratio as the population of the State has to the population of all States (section 304(a)(2)). State populations are determined on the basis of the most recent census data available to the Secretary of HHS and, the Secretary shall use for such purpose, if available, the annual current interim census data produced by the Secretary of Commerce pursuant to section 181 of Title 13. For the purpose of computing allotments, the statute provides that Guam, American Samoa, the Virgin Islands, and the Northern Mariana Islands will each receive grants of not less than one-eighth of one percent of the amounts appropriated (section 304(a)(1)). Expenditure Period FVPSA funds may be used for expenditures on and after October 1 of each fiscal year for which they are granted, and will be available for expenditure through September 30 of the following fiscal year, i.e., FY 2007 funds may be used for expenditures from October 1, 2006, through September 30, 2008. Funds are available for obligation through September 30, 2008, and must be liquidated by September 30, 2009. Re-allotted funds, if any, are available for expenditure until the end of the fiscal year following the fiscal year that the funds became available for re-allotment. FY 2007 grant funds that are made available to the States through re-allotment, under section 304(d)(2), must be expended by the State no later than September 30, 2008. III. Eligibility “States” as defined in section 320 of FVPSA are eligible to apply for funds. The term “State” means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the Virgin Islands, and the Commonwealth of the Northern Mariana Islands. In the past, Guam, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, and American Samoa have applied for funds as a part of their consolidated grant under the Social Services Block grant. These jurisdictions need not submit an application under this program announcement if they choose to have their allotment included as part of a consolidated grant application. Additional Information on Eligibility D-U-N-S Requirement All applicants must have a D&B Data Universal Numbering System (D-U-N-S) number. On June 27, 2003, the Office of Management and Budget

(1)The name of the State agency, the name of the Chief Program Official designated as responsible for the administration of funds under FVPSA and coordination of related programs within the State, and the name of a contact person if different from the Chief Program Official (section 303(a)(2)(D)).

(2)A plan describing in detail how the needs of underserved populations will be met. “Underserved populations” include populations underserved because of geographic location (such as rural isolation), underserved racial and ethnic populations, populations underserved because of special needs (such as language barriers, disabilities, alienage status, or age), and any other population determined to be underserved by the State planning process in consultation with the Attorney General (section 303(a)(2)(C)).

(a)Identify the underserved populations that are being targeted for outreach and services.

(b)In meeting the needs of the underserved population, describe the domestic violence training that will be provided to the individuals who will do the outreach and intervention to these populations. Describe the specific service environment, e.g., new shelters; services for the battered, elderly, women of color, etc.

(c)Describe the public information component of the State's outreach program; the elements of the program that are used to explain domestic violence, the most effective and safe ways to seek help; tools to identify available resources, etc.

(3)Provide a complete description of the process and procedures used to involve State domestic violence coalitions, knowledgeable individuals, and interested organizations, and assure whether a grantee is in compliance with section 303(a)(2) as required by sections 303 (a)(2)(C) and 311(a)(5).

(4)Provide a complete description of the process and procedures to be implemented that allow for the participation of the State domestic violence coalition in planning and monitoring the distribution of grant funds and determining whether a grantee is in compliance with section 303(a)(2) as required by sections 303(a)(2)(C) and 311(a)(5).

(5)Provide a copy of the procedures developed and implemented that assure the confidentiality of records pertaining to any individual who has been provided family violence prevention or treatment services by any program assisted under FVPSA (section 303(a)(2)(E)).

(6)Include a description of how the State plans to use the grant funds; a description of the target population; the number of shelters to be funded; the services the State will provide; and the expected results from the use of the grant funds (section 303(a)(2)).

(7)Provide a copy of the law or procedures that the State has implemented for the eviction of an abusive spouse from a shared household (section 303 (a)(2)(F)). Assurances Each application must provide the following assurances:

(1)That grant funds under FVPSA will be distributed to local public agencies and non-profit private organizations (including religious and charitable organizations and voluntary associations) for programs and projects within the State to prevent incidents of family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents in order to prevent future violent incidents (section 303(a)(2)(A)).

(2)That not less than 70 percent of the funds distributed shall be used for immediate shelter and related assistance, as defined in section 320(5)(A), to the victims of family violence and their dependents and not less than 25 percent of the funds distributed shall be used to provide related assistance (section 303(g)).

(3)That not more than five percent of the funds will be used for State administrative costs (section 303(a)(2)(B)(i)).

(4)That in distributing the funds, the States will give special emphasis to the support of community-based projects of demonstrated effectiveness carried out by non-profit, private organizations, particularly for those projects where the primary purpose is to operate shelters for victims of family violence and their dependents and those which provide counseling, advocacy, and self-help services to victims and their children (section 303(a)(2)(B)(ii)).

(5)That grants funded by the States will meet the matching requirements in section 303(f), i.e., not less than 20 percent of the total funds provided for a project under Chapter 110 of Title 42 of the U.S.C. with respect to an existing program, and with respect to an entity intending to operate a new program under this Title, not less than 35 percent. The local share will be cash or in-kind; and the local share will not include any Federal funds provided under any authority other than this chapter (section 303(f)).

(6)That grant funds made available under this program by the State will not be used as direct payment to any victim or dependent of a victim of family violence (section 303(d)).

(7)That no income eligibility standard will be imposed on individuals receiving assistance or services supported with funds appropriated to carry out FVPSA (section 303(e)).

(8)That the address or location of any shelter-facility assisted under FVPSA will not be made public, except with the written authorization of the person or persons responsible for the operation of such shelter (section 303(a)(2)(E)).

(9)That all grants, programs or other activities funded by the State in whole or in part with funds made available under FVPSA will prohibit discrimination on the basis of age, handicap, sex, race, color, national origin or religion (section 307).

(10)That funds made available under the FVPSA will be used to supplement and not supplant other Federal, State and local public funds expended to provide services and activities that promote the purposes of the FVPSA (section 303(a)(4). Certifications All applications must submit or comply with the required certifications found in the Appendices as follows: *Anti-Lobbying Certification and Disclosure Form (See Appendix A):* Applicants who have used non-Federal funds for lobbying activities in connection with receiving assistance under this announcement shall complete a disclosure form, if applicable, with their applications (approved by OMB under control number 0348-0046). Applicants should sign and return the certification with their application. *Certification Regarding Environmental Tobacco Smoke (See Appendix B):* Applicants must also understand they will be held accountable for the smoking prohibition included within Pub. L. 103-227, Title XII Environmental Tobacco Smoke (also known as the Pro Children Act of 1994). A copy of the **Federal Register** notice which implements the smoking prohibition is included with the forms. By signing and submitting the application, applicants are providing the certification and need not mail back the certification with the application. *Certification Regarding Drug-Free Workplace Requirements (See Appendix C):* The signature on the application by the chief program official attests to the applicant's intent to comply with the Drug-Free Workplace requirements and compliance with the Debarment Certification. The Drug-Free Workplace certification does not have to be returned with the application. These certifications also may be found at *http://www.acf.hhs.gov/programs/ofs/forms.htm* . Notification Under Executive Order 12372 For States, this program is covered under Executive Order 12372, “Intergovernmental Review of Federal Programs,” for State plan consolidation and implication only—45 Code of Federal Regulations

(CFR)100.12. The review and comment provisions of the Executive Order and Part 100 do not apply. Applications should be sent to: Family and Youth Services Bureau, Administration on Children, Youth and Families, Administration for Children and Families, Attention: Ms. Sunni Knight, 1250 Maryland Avenue, SW., Room 8240, Washington, DC 20024. V. Approval/Disapproval of a State Application The Secretary of HHS will approve any application that meets the requirements of FVPSA and this announcement and will not disapprove any such application except after reasonable notice of the Secretary's intention to disapprove has been provided to the applicant and after a six-month period providing an opportunity for the applicant to correct any deficiencies. The notice of intention to disapprove will be provided to the applicant within 45 days of the date of the application. VI. Reporting Requirements Performance Reports Section 303(a)(4) requires that States file a performance report with HHS describing the activities carried out, and inclusion of an assessment of the effectiveness of those activities in achieving the purposes of the grant. Section 303(a)(5) requires that the State file a report that contains a description of the activities carried out with funds expended for State administrative costs. A section of this performance report must be completed by each grantee or sub-grantee that performed the direct services contemplated in the State's application certifying performance of such services. State grantees should compile performance reports into a comprehensive report for submission. The Performance Report should include the following data elements as well as narrative examples of success stories about the services that were provided. The Performance Report should include the following data elements: *Funding* —The total amount of the FVPSA grant funds awarded. The percentage of FVPSA funds as a portion of total funding. The percentage of FVPSA funding used for shelters, and the percentage of funding used for related assistance and services. *Shelters* —The total number of shelters and shelter alternatives (safe homes/motels, etc.) assisted by FVPSA program funding. Data elements should include: • The number of women sheltered. • The number of shelters in the State. • The number of safe houses and shelter alternatives in the State. • The number of non-residential programs assisted by FVPSA in the State. • The number of young children sheltered (birth-12 years of age). • The number of teenagers and young adults sheltered (13-18 years of age). • The number of men sheltered. • The number of elderly sheltered (greater than 55 years of age). • The number of elderly individuals provided non-residential services. • The average length of shelter stay. • The number of women, children, teens, and others who at were referred to other shelters due to a lack of space. *Types of individuals served* —Record information by numbers and percentages of the total population served. Individuals and special populations served should include: • Elderly; and • Individuals with physical challenges. *Related assistance and services* —List the types of related assistance and services provided to victims and their family members by indicating the number of women, children and men who have received services. Services and assistance may include, but are not limited to, the following: • Individual counseling; • Group counseling; • Crisis intervention hotline; • Information and referral; • Batterers' support services; • Legal advocacy services; • Transportation; • Services to teenagers; • Emergency child care; • Training and technical assistance; and • Housing advocacy. *Volunteers* —List the total number of volunteers and hours worked. *Service referrals* —List the number of women, children and men referred for the following service reasons: • Physical abuse; • Alcohol abuse; • Drug abuse; • Batterer intervention services; • Emergency medical intervention; and • Law enforcement intervention. *Narratives of success stories* —Provide narratives of success stories of services provided and the positive impact on the lives of children and families. Examples may include the following: • An explanation of the activities carried out, including an assessment of the major activities supported by the family violence funds, what particular priorities within the State were addressed and what special emphases were placed on these activities; • A description of the specific services and facilities that the applicant's agency funded, contracted with, or otherwise used in the implementation of its program (e.g., shelters, safe-houses, related assistance, programs for batterers); • An assessment of the effectiveness of the direct service activities contemplated in the application; • A description of how the needs of under-served populations, including populations under-served because of ethnic, racial, cultural, language diversity or geographic isolation were addressed; • A description and assessment of the prevention activities supported during the program year, e.g., community education events, and public awareness efforts; and • A discussion of exceptional issues or problems arising, but not addressed, in the application. Performance Reports for the States are due on an annual basis at the end of the calendar year (December 29). Performance Reports should be sent to: Family Violence Prevention and Services Program, Family and Youth Services Bureau, Administration on Children, Youth and Families, Administration for Children and Families, Attention: William D. Riley, 1250 Maryland Avenue, SW., Room 8402, Washington, DC 20024. Please note that section 303(a)(4) of FVPSA requires HHS to suspend funding for an approved application if any State applicant fails to submit an annual Performance Report or if the funds are expended for purposes other than those set forth under this announcement. Financial Status Reports Grantees must submit annual Financial Status Reports. The first SF-269A is due December 29, 2007. It covers expenditures from date of award through September 30, 2007. The interim SF-269A is due December 29, 2008. The final SF-269A is due December 29, 2009. SF-269A can be found at *http://www.whitehouse.gov/omb/grants/grants_forms.html.* Completed reports may be mailed to: Rachel Hickson, Division of Mandatory Grants, Office of Grants Management, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447. Grantees have the option of submitting their reports online through the Online Data Collection

(OLDC)system at the following address: *https://extranet.acf.hhs.gov/ssi.* The Division of Mandatory Grants can assist grantees with access to OLDC. Failure to submit reports on time may be a basis for withholding grant funds, suspension or termination of the grant. All funds reported as unobligated after the obligation period will be recouped. VII. Administrative and National Policy Requirements States will comply with the applicable HHS recordkeeping and reporting requirements and general requirements for the administration of grants under 45 CFR Part 92. Direct Federal grants, sub-award funds, or contracts under this ACF program shall not be used to support inherently religious activities such as religious instruction, worship, or proselytization. Therefore, organizations must take steps to separate, in time or location, their inherently religious activities from the services funded under this program. Regulations pertaining to Equal Treatment for Faith-Based Organizations, which includes the prohibition against Federal funding of inherently religious activities, can be found at the HHS Web site at: *http://www.hhs.gov/fbci/regs.html.* Faith-based and community organizations may reference the “Guidance to Faith-Based and Community Organizations on Partnering with the Federal Government” at: *http://www.whitehouse.gov/government/fbci/guidance/index.html.* VIII. Other Information *For Further Information Contact:* William D. Riley at

(202)401-5529 or e-mail at *WRiley@acf.hhs.gov,* or Sunni Knight at

(202)401-5319 or e-mail at *GKnight@acf.hhs.gov.* Dated: January 4, 2007. Joan E. Ohl, Commissioner, Administration on Children, Youth and Families. Appendices—Required Certifications A. Certification Regarding Lobbying B. Environmental Tobacco Smoke C. Drug-Free Workplace Requirements Appendix A—Certification Regarding Lobbying Certification for Contracts, Grants, Loans, and Cooperative Agreements The undersigned certifies, to the best of his or her knowledge and belief, that:

(3)The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Statement for Loan Guarantees and Loan Insurance The undersigned states, to the best of his or her knowledge and belief, that: If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this commitment providing for the United States to insure or guarantee a loan, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions. Submission of this statement is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Signature Title Organization Appendix B—Certification Regarding Environmental Tobacco Smoke Public Law 103227, Part C Environmental Tobacco Smoke, also known as the Pro Children Act of 1994 (Act), requires that smoking not be permitted in any portion of any indoor routinely owned or leased or contracted for by an entity and used routinely or regularly for provision of health, day care, education, or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law does not apply to children's services provided in private residences, facilities funded solely by Medicare or Medicaid funds, and portions of facilities used for inpatient drug or alcohol treatment. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1000 per day and/or the imposition of an administrative compliance order on the responsible entity. By signing and submitting this application the applicant/grantee certifies that it will comply with the requirements of the Act. The applicant/grantee further agrees that it will require the language of this certification be included in any subawards which contain provisions for the children's services and that all subgrantees shall certify accordingly. Appendix C—Certification Regarding Drug-Free Workplace Requirements This certification is required by the regulations implementing the Drug-Free Workplace Act of 1988: 45 CFR Part 76, Subpart, F. Sections 76.630(c) and (d)(2) and 76.645(a)(1) and

(b)provide that a Federal agency may designate a central receipt point for STATE-WIDE AND STATE AGENCY-WIDE certifications, and for notification of criminal drug convictions. For the Department of Health and Human Services, the central pint is: Division of Grants Management and Oversight, Office of Management and Acquisition, Department of Health and Human Services, Room 517-D, 200 Independence Avenue, SW., Washington, DC 20201. Certification Regarding Drug-Free Workplace Requirements (Instructions for Certification) 1. By signing and/or submitting this application or grant agreement, the grantee is providing the certification set out below. 2. The certification set out below is a material representation of fact upon which reliance is placed when the agency awards the grant. If it is later determined that the grantee knowingly rendered a false certification, or otherwise violates the requirements of the Drug-Free Workplace Act, the agency, in addition to any other remedies available to the Federal Government, may take action authorized under the Drug-Free Workplace Act. 3. For grantees other than individuals, Alternate I applies. 4. For grantees who are individuals, Alternate II applies. 5. Workplaces under grants, for grantees other than individuals, need not be identified on the certification. If known, they may be identified in the grant application. If the grantee does not identify the workplaces at the time of application, or upon award, if there is no application, the grantee must keep the identity of the workplace(s) on file in its office and make the information available for Federal inspection. Failure to identify all known workplaces constitutes a violation of the grantee's drug-free workplace requirements. 6. Workplace identifications must include the actual address of buildings (or parts of buildings) or other sites where work under the grant takes place. Categorical descriptions may be used (e.g., all vehicles of a mass transit authority or State highway department while in operation, State employees in each local unemployment office, performers in concert halls or radio studios). 7. If the workplace identified to the agency changes during the performance of the grant, the grantee shall inform the agency of the change(s), if it previously identified the workplaces in question (see paragraph five). 8. Definitions of terms in the Nonprocurement Suspension and Debarment common rule and Drug-Free Workplace common rule apply to this certification. Grantees' attention is called, in particular, to the following definitions from these rules: *Controlled substance* means a controlled substance in Schedules I through V of the Controlled Substances Act (21 U.S.C. 812) and as further defined by regulation (21 CFR 1308.11 through 1308.15); *Conviction* means a finding of guilt (including a plea of nolo contendere) or imposition of sentence, or both, by any judicial body charged with the responsibility to determine violations of the Federal or State criminal drug statutes; *Criminal drug statute* means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, use, or possession of any controlled substance; *Employee* means the employee of a grantee directly engaged in the performance of work under a grant, including:

(i)All direct charge employees;

(ii)All indirect charge employees unless their impact or involvement is insignificant to the performance of the grant; and,

(iii)Temporary personnel and consultants who are directly engaged in the performance of work under the grant and who are on the grantee's payroll. This definition does not include workers not on the payroll of the grantee (e.g., volunteers, even if used to meet a matching requirement; consultants or independent contractors not on the grantee's payroll; or employees of subrecipients or subcontractors in covered workplaces). Certification Regarding Drug-Free Workplace Requirements Alternate I. (Grantees Other Than Individuals) The grantee certifies that it will or will continue to provide a drug-free workplace by:

(b)Establishing an ongoing drug-free awareness program to inform employees about—

(1)The dangers of drug abuse in the workplace;

(2)The grantee's policy of maintaining a drug-free workplace;

(3)Any available drug counseling, rehabilitation, and employee assistance programs; and

(4)The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(c)Making it a requirement that each employee to be engaged in the performance of the grant be given a copy of the statement required by paragraph (a);

(d)Notifying the employee in the statement required by paragraph

(a)that, as a condition of employment under the grant, the employee will—

(1)Abide by the terms of the statement; and

(2)Notify the employer in writing of his or her conviction for a violation of a criminal drug statute occurring in the workplace no later than five calendar days after such conviction;

(f)Taking one of the following actions, within 30 calendar days of receiving notice under paragraph (d)(2), with respect to any employee who is so convicted—

(1)Taking appropriate personnel action against such an employee, up to and including termination, consistent with the requirements of the Rehabilitation Act of 1973, as amended; or

(g)Making a good faith effort to continue to maintain a drug-free workplace through implementation of paragraphs (a), (b), (c), (d),

(e)and (f).

(FYSB)*Program Announcement Number:* HHS-2007-ACF-ACYF-SDVC-0122 *Announcement Title:* Family Violence Prevention and Services/Grants to State Domestic Violence Coalitions *CFDA Number:* 93.591 *Due Date for Applications:* February 15, 2007. *Executive Summary:* This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to private, non-profit State Domestic Violence Coalitions (Coalitions). The purpose of these grants is to assist in the conduct of activities to promote domestic violence intervention and prevention and to increase public awareness of domestic violence issues. This notice for family violence prevention and services grants to Coalitions serves two purposes. The first is to confirm a Federal commitment to reducing domestic violence; and the second purpose is to urge States, localities, cities, and the private sector to become involved in State and local planning towards an integrated service delivery approach. I. Description *Legislative Authority:* Title III of the Child Abuse Amendments of 1984 (Pubic Law (Pub L.) 98-457, 42 United States Code (U.S.C.) 10401 et seq.) is entitled the “Family Violence Prevention and Services Act” (FVPSA). FVPSA was first implemented in Fiscal Year

(FY)1986. The statute was subsequently amended by Pub L. 100-294, the “Child Abuse Prevention, Adoptions, and Family Services Act of 1988;” further amended in 1992 by Pub L. 102-295; and then amended in 1994 by Pub L. 103-322, the “Violent Crime Control and Law Enforcement Act.” FVPSA was amended again in 1996 by Pub L. 104-235, the “Child Abuse Prevention and Treatment Act (CAPTA) of 1996;” in 2000 by Pub L. 106-386, the “Victims of Trafficking and Violence Protection Act,” and amended further by Pub L. 108-36, the “Keeping Children and Families Safe Act of 2003.” FVPSA was most recently amended by Pub L. 109-162, the “Violence Against Women Reauthorization Act of 2005” and by Pub L. 109-271, which was enacted on August 17, 2006.” Background Section 311 of FVPSA authorizes the U.S. Department of Health and Human Services

(HHS)Secretary to award grants to statewide, private, non-profit Coalitions to conduct activities to promote domestic violence intervention and prevention and to increase public awareness of domestic violence issues. Annual State Domestic Violence Coalition Grantee Conference Coalitions should plan to send one or more representatives to the annual grantee conference. A subsequent Program Instruction and/or Information Memorandum will advise Coalition administrators of the date, time, and location of their grantee conference. Client Confidentiality FVPSA programs must establish or implement policies and protocols for maintaining the safety and confidentiality of the adult victims and their children of domestic violence, sexual assault, and stalking. It is essential that the confidentiality of individuals receiving FVPSA services be protected. Consequently, when providing statistical data on program activities and program services, individual identifiers of client records will not be used (see Section 303(a)(2)(E)). The confidentiality provisions described at 42 U.S.C., 13701, apply to programs funded under the Violence Against Women Act, as amended, including certain awards made under the Family Violence Prevention and Services Act. These confidentiality requirements were strengthened and clarified with the passage of the Violence Against Women Reauthorization Act of 2005, Pub L. 109-162, as recently amended by Pub L. 109-271. The revised confidentiality provisions impose conditions regarding the disclosure of personally identifying information, confidentiality, information sharing, and compulsory release of information.” Stop Family Violence Postal Stamp The U.S. Postal Service was directed by the “Stamp Out Domestic Violence Act of 2001” (the Act), Pub L. 107-62, to make available a “semipostal” stamp to provide funding for domestic violence programs. Funds raised in connection with sales of the stamp, less reasonable costs, have been transferred to HHS in accordance with the Act for support of services to children and youth affected by domestic violence. As of FY 2006, $2.3 million has been transferred and made available in support of grants for “Demonstration Programs for the Enhanced Services to Children and Youth Who Have Been Exposed to Domestic Violence.” Sixty-five

(65)applications were received and reviewed in FY2005 and nine

(9)successful applicants are in the second year of their projects. The project sites are in Castle Rock, CO; Harrisburg, PA; Oklahoma City, OK: Oakland, CA.; Albany, NY; Lansing, MI; Richmond, VA; and Washington, DC. ACF anticipates information on the progress and activities of the successful applicants and their programs in FY 2007. The Importance of Coordination of Services The impacts of domestic violence include physical injury and death of primary or secondary victims, psychological trauma, isolation from family and friends, harm to children witnessing or experiencing violence in homes in which the violence occurs, increased fear, reduced mobility and employability, homelessness, substance abuse, and a host of other health and related mental health consequences. Coordination and collaboration among the police, prosecutors, the courts, victim services providers, child welfare and family preservation services, and medical and mental health service providers is needed to provide more responsive and effective services to victims of domestic violence and their families. It is essential that all interested parties are involved in the design and improvements of intervention and prevention activities. To help bring about a more effective response to the problem of domestic violence, HHS urges the designated Coalitions receiving funds under this grant announcement to continue to coordinate activities funded under this grant with other new and existing resources for the prevention of family and intimate violence and related issues. National Data Collection and Outcomes Measurement The need to accurately communicate reliable and appropriate data that capture the impact of domestic violence prevention and intervention efforts and to provide shelters, States, and Coalitions with tools for self-assessment continues as the Documenting our Work

(DOW)Initiative. In collaboration with our partners at the State FVPSA programs, Coalitions, and experts on both data collection and domestic violence prevention issues, the effort to develop informative, succinct, and non-burdensome reporting formats continues. During FY 2006 and in concert with State FVPSA administrators, Coalitions and local service providers, four states have volunteered as pilot sites to assess proposed program reporting procedures and test the reliability of the outcome measures for FVPSA programs. Any recommended changes for information and reporting formats will be accompanied by specifically designated workshops or adjunctive discussions to regularly occurring meetings. II. Funds Available In FY 2007, HHS will make 10 percent of the amount appropriated under section 310(a)(1) of the FVPSA, which is not reserved under section 310(a)(2), available for grants to the State-designated, statewide, domestic violence Coalitions. One grant will be available for each of the Coalitions in the 50 States, the Commonwealth of Puerto Rico, and the District of Columbia. The Coalitions of the U.S. Territories (Guam, U.S. Virgin Islands, Northern Mariana Islands, American Samoa, and Trust Territory of the Pacific Islands) are also eligible for grant awards under this announcement. Expenditure Period FVPSA funds may be used for expenditures on or after October 1 of each fiscal year for which they are granted and will be available for expenditure through September 30 of the following fiscal year, i.e., FY 2007 funds may be used for expenditures from October 1, 2006, through September 30, 2008. Funds are available for obligation through September 30, 2008, and must be liquidated by September 30, 2009. III. Eligibility To be eligible for grants under this program announcement, an organization shall be designated as a statewide, private, non-profit domestic violence coalition meeting the following criteria:

(1)The membership of the Coalition includes representatives from a majority of the programs for victims of domestic violence operating within the State (a Coalition may include representatives of Indian Tribes and Tribal organizations as defined in the Indian Self-Determination and Education Assistance Act);

(2)The Board membership of the Coalition is representative of such programs;

(3)The purpose of the Coalition is to provide services, community education, and technical assistance to domestic violence programs in order to establish and maintain shelter and related services for victims of domestic violence and their children; and

(4)In the application submitted by the Coalition for the grant, the Coalition provides assurances satisfactory to the Secretary that the Coalition:

(a)Has actively sought and encouraged the participation of law enforcement agencies and other legal or judicial entities in the preparation of the application; and

(b)Will actively seek and encourage the participation of such entities in the activities carried out with the grant (Section 311(b)(4)). Additional Information on Eligibility D-U-N-S Requirement All applicants must have a D&B Data Universal Numbering System (D-U-N-S) number. On June 27, 2003, the Office of Management and Budget

(OMB)published in the **Federal Register** a new Federal policy applicable to all Federal grant applicants. The policy requires Federal grant applicants to provide a D-U-N-S number when applying for Federal grants or cooperative agreements on or after October 1, 2003. The D-U-N-S number will be required whether an applicant is submitting a paper application or using the government-wide electronic portal, *Grants.gov* . A D-U-N-S number will be required for every application for a new award or renewal/continuation of an award, including applications or plans under formula, entitlement, and block grant programs, submitted on or after October 1, 2003. Please ensure that the applicant's organization has a D-U-N-S number. To acquire a D-U-N-S number at no cost call the dedicated toll-free D-U-N-S number request line at 1-866-705-5711 or request a number on-line at *http://www.dnb.com* . Survey for Private Non-Profit Grant Applicants Private, non-profit organizations are encouraged to submit with their applications the survey located under “Grant Related Documents and Forms,” “Survey for Private, Non-Profit Grant Applicants,” titled, “Survey on Ensuring Equal Opportunity for Applicants,” at: *http://www.acf.hhs.gov/programs/ofs/forms.htm* . IV. Application Requirements For State Domestic Violence Coalition (Coalitions) Applications This section includes application requirements for family violence prevention and services grants for Coalitions, as follows: The Paperwork Reduction Act of 1995 (Pub L. 104-13) Public reporting burden for this collection of information is estimated to average six hours per response, including the time for reviewing instructions, gathering and maintaining the data needed and reviewing the collection information. The project description is approved under the Office of Management and Budget

(1)A description of the process and anticipated outcomes of utilizing these Federal funds to work with local domestic violence programs and providers of direct services to encourage appropriate responses to domestic violence within the State, including—Training and technical assistance for local programs and professionals working in the field:

(a)Planning and conducting State needs assessments and planning for comprehensive services;

(b)Serving as an information clearinghouse and resource center for the State; and

(c)Collaborating with other governmental systems that affect battered women (Section 311(a)(1)).

(2)A description of the public education campaign regarding domestic violence to be conducted by the Coalition through the use of public service announcements and informative materials that are designed for print media; billboards; public transit advertising; electronic broadcast media; and other forms of information dissemination that inform the public about domestic violence, including information aimed at underserved racial, ethnic or language-minority populations (Section 311(a)(4)).

(3)The anticipated outcomes and a description of planned grant activities to be conducted in conjunction with judicial and law enforcement agencies concerning appropriate responses to domestic violence cases and an examination of related issues as set forth in Section 311(a)(2) of the FVPSA.

(4)The anticipated outcomes and a description of planned grant activities to be conducted in conjunction with Family Law Judges, Criminal Court Judges, Child Protective Services agencies, Child Welfare agencies, Family Preservation and Support Service agencies, and children's advocates to develop appropriate responses to child custody and visitation issues in domestic violence cases and in cases where domestic violence and child abuse are both present. Appropriate responses identified in section 311(a)(3) of the FVPSA should be included. The anticipated outcomes and a description of other activities in support of the general purpose of furthering domestic violence intervention and prevention (Section 311(a)(3)).

(5)The following documentation will certify the status of the Coalition and must be included in the grant application:

(a)A description of the procedures developed between the State domestic violence agency and the statewide Coalition that allow for implementation of the following cooperative activities:

(i)The participation of the Coalition in the planning and monitoring of the distribution of grants and grant funds provided in the State (Section 311(a)(5)); and

(ii)The participation of the Coalition in compliance activities regarding the State's family violence prevention and services program grantees (Sections 303(a)(2)(C) and (a)(3)).

(b)Unless already on file at HHS, a copy of a currently valid 501(c)(3) certification letter from the IRS stating private, non-profit status; or a copy of the applicant's listing in the IRS' most recent list of tax-exempt organizations described in Section 501(c)(3) of the IRS code; or

(c)A copy of the articles of incorporation bearing the seal of the State in which the corporation or association is domiciled;

(d)A current list of the organizations operating programs for victims of domestic violence programs in the State and the applicant Coalition's current membership list by organization;

(e)A list of the applicant Coalition's current Board of Directors, with each individual's organizational affiliation and the Chairperson identified;

(f)A copy of the resume of any Coalition or contractual staff to be supported by funds from this grant and/or a statement of requirements for staff or consultants to be hired under this grant; and

(g)A budget narrative that clearly describes the planned expenditure of funds under this grant.

(6)Required Documentation and Assurances (included in the application as an appendix):

(a)The applicant Coalition must provide documentation in the form of support letters, memoranda of agreement, or jointly signed statements, that the Coalition:

(i)Has actively sought and encouraged the participation of law enforcement agencies and other legal or judicial organizations in the preparation of the grant application (Section 311(b)(4)(A)); and

(ii)Will actively seek and encourage the participation of such organizations in grant funded activities (Section 311(b)(4)(B)).

(b)The applicant Coalition must provide a signed statement that the Coalition will not use grant funds, directly or indirectly, to influence the issuance, amendment, or revocation of any Executive Order or similar legal document by any Federal, State or local agency, or to undertake to influence the passage or defeat of any legislation by the Congress, or any State, or local legislative body, or State proposals by initiative petition, except where representatives of the Coalition are testifying, or making other appropriate communications, or when formally requested to do so by a legislative body, a committee, or a member of such organization (Section 311(d)(1)); or in connection with legislation or appropriations directly affecting the activities of the Coalition or any member of the Coalition (Section 311(d)(2)).

(c)The applicant Coalition must provide a signed statement that the Coalition will prohibit discrimination on the basis of age, handicap, sex, race, color, national origin or religion (Section 307).

(d)The applicant will comply with Departmental requirements for the administration of grants under 45 CFR Part 74—Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-profit Organizations and Commercial Organizations. Certifications All applicants must submit or comply with the required certifications found in the Appendices, as follows: *Certification Regarding Lobbying (See Appendix A):* Applicants who have used non-Federal funds for lobbying activities in connection with receiving assistance under this announcement shall complete a disclosure form, if applicable, with their applications (approved by OMB under control number 0348-0046). Applicants should sign and return the certification with their application. *Certification Regarding Environmental Tobacco Smoke (See Appendix B):* Applicants must also understand they will be held accountable for the smoking prohibition included within Pub.L. 103-227, Title XII Environmental Tobacco Smoke (also known as the Pro-Children Act of 1994). A copy of the **Federal Register** notice that implements the smoking prohibition is included with the forms. By signing and submitting the application, applicants are providing the certification and need not mail back the certification with the application. *Certification Regarding Drug-Free Workplace Requirements (See Appendix C):* The signature on the application by the program official attests to the applicants' intent to comply with the Drug-Free Workplace requirements and compliance with the Debarment Certification. The Drug-Free Workplace certification does not have to be returned with the application. These certifications also may be found at *http://www.acf.hhs.gov/programs/ofs/forms.htm.* Notification Under Executive Order 12372 This program is covered under Executive Order 12372, “Intergovernmental Review of Federal Programs” for State plan consolidation and simplification only—45 CFR 100.12. The review and comment provisions of the Executive Order and Part 100 do not apply. *Applications should be sent to:* Family and Youth Services Bureau, Administration on Children, Youth and Families, Administration for Children and Families, *Attention:* William D. Riley, 1250 Maryland Avenue, SW., Room 8402, Washington, DC 20024. V. Reporting Requirements Performance Reports The Coalition grantee must submit an annual report of activities describing the coordination, training and technical assistance, needs assessment, and comprehensive planning activities carried out. Additionally, the Coalition must report on the public information and education services provided; the activities conducted in conjunction with judicial and law enforcement agencies; the actions conducted in conjunction with other agencies such as the State child welfare agency; and any other activities undertaken under this grant award. The annual report also must provide an assessment of the effectiveness of the grant-supported activities. The annual report is due 90 days after the end of the fiscal year in which the grant is awarded, i.e., December 29. Annual reports should be sent to: Family and Youth Services Bureau, Administration on Children, Youth and Families, Administration for Children and Families, *Attention:* William D. Riley, 1250 Maryland Avenue, SW., Room 8402, Washington, DC 20024. Please note that HHS may suspend funding for an approved application if any applicant fails to submit an annual performance report or if the funds are expended for purposes other than those set forth under this announcement. Financial Status Reports Grantees must submit annual Financial Status Reports. The first SF-269A is due December 29, 2007. It covers expenditures from date of award through September 30, 2007. The interim SF-269A is due December 29, 2008. The final SF-269A is due December 29, 2009. SF-269A can be found at the following URL: *http://www.whitehouse.gov/omb/grants/grants_forms.html.* *Completed reports should be sent to:* Rachel Hickson, Division of Mandatory Grants, Office of Grants Management, Office of Administration, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447. Grantees have the option to submit their reports online through the Online Data Collection

(OLDC)system at the following address: *https://extranet.acf.hhs.gov/ssi.* The Division of Mandatory Grants can assist grantees with access to OLDC. Failure to submit reports on time may be a basis for withholding grant funds, suspension or termination of the grant. In addition, all funds reported after the obligation period will be recouped. VI. Administrative and National Policy Requirements Grantees are subject to the requirements in 45 CFR Part 74. Direct Federal grants, sub-award funds, or contracts under this ACF program shall not be used to support inherently religious activities such as religious instruction, worship, or proselytization. Therefore, organizations must take steps to separate, in time or location, their inherently religious activities from the services funded under this program. Regulations pertaining to Equal Treatment for Faith-Based Organizations, which includes the prohibition against Federal funding of inherently religious activities, can be found at the HHS Web site at *http://www.hhs.gov/fbci/regs.html.* Faith-based and community organizations may reference the “Guidance to Faith-Based and Community Organizations on Partnering with the Federal Government” at *http://www.whitehouse.gov/government/fbci/guidance/index.html.* VII. Other Information *For Further Information Contact:* William D. Riley at

(202)401-5529 or e-mail at *WRiley@acf.hhs.gov.* Dated: January 4, 2007. Joan E. Ohl, Commissioner, Administration on Children, Youth, and Families. Appendices: Required Certifications A. Certification Regarding Lobbying B. Environmental Tobacco Smoke C. Drug-Free Workplace Requirements Appendix A—Certification Regarding Lobbying Certification for Contracts, Grants, Loans, and Cooperative Agreements The undersigned certifies, to the best of his or her knowledge and belief, that:

(3)The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Statement for Loan Guarantees and Loan Insurance The undersigned states, to the best of his or her knowledge and belief, that: If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this commitment providing for the United States to insure or guarantee a loan, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions. Submission of this statement is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Signature Title Organization Appendix B—Certification Regarding Environmental Tobacco Smoke Public Law 103227, Part C Environmental Tobacco Smoke, also known as the Pro Children Act of 1994 (Act), requires that smoking not be permitted in any portion of any indoor routinely owned or leased or contracted for by an entity and used routinely or regularly for provision of health, day care, education, or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law does not apply to children's services provided in private residences, facilities funded solely by Medicare or Medicaid funds, and portions of facilities used for inpatient drug or alcohol treatment. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1000 per day and/or the imposition of an administrative compliance order on the responsible entity. By signing and submitting this application the applicant/grantee certifies that it will comply with the requirements of the Act. The applicant/grantee further agrees that it will require the language of this certification be included in any subawards which contain provisions for the children's services and that all subgrantees shall certify accordingly. Appendix C—Certification Regarding Drug-Free Workplace Requirements This certification is required by the regulations implementing the Drug-Free Workplace Act of 1988: 45 CFR Part 76, Subpart, F. Sections 76.630(c) and (d)(2) and 76.645(a)(1) and

(b)provide that a Federal agency may designate a central receipt point for STATE-WIDE AND STATE AGENCY-WIDE certifications, and for notification of criminal drug convictions. For the Department of Health and Human Services, the central pint is: Division of Grants Management and Oversight, Office of Management and Acquisition, Department of Health and Human Services, Room 517-D, 200 Independence Avenue, SW., Washington, DC 20201. Certification Regarding Drug-Free Workplace Requirements (Instructions for Certification) 1. By signing and/or submitting this application or grant agreement, the grantee is providing the certification set out below. 2. The certification set out below is a material representation of fact upon which reliance is placed when the agency awards the grant. If it is later determined that the grantee knowingly rendered a false certification, or otherwise violates the requirements of the Drug-Free Workplace Act, the agency, in addition to any other remedies available to the Federal Government, may take action authorized under the Drug-Free Workplace Act. 3. For grantees other than individuals, Alternate I applies. 4. For grantees who are individuals, Alternate II applies. 5. Workplaces under grants, for grantees other than individuals, need not be identified on the certification. If known, they may be identified in the grant application. If the grantee does not identify the workplaces at the time of application, or upon award, if there is no application, the grantee must keep the identity of the workplace(s) on file in its office and make the information available for Federal inspection. Failure to identify all known workplaces constitutes a violation of the grantee's drug-free workplace requirements. 6. Workplace identifications must include the actual address of buildings (or parts of buildings) or other sites where work under the grant takes place. Categorical descriptions may be used (e.g., all vehicles of a mass transit authority or State highway department while in operation, State employees in each local unemployment office, performers in concert halls or radio studios). 7. If the workplace identified to the agency changes during the performance of the grant, the grantee shall inform the agency of the change(s), if it previously identified the workplaces in question (see paragraph five). 8. Definitions of terms in the Nonprocurement Suspension and Debarment common rule and Drug-Free Workplace common rule apply to this certification. Grantees' attention is called, in particular, to the following definitions from these rules: *Controlled substance* means a controlled substance in Schedules I through V of the Controlled Substances Act (21 U.S.C. 812) and as further defined by regulation (21 CFR 1308.11 through 1308.15); *Conviction* means a finding of guilt (including a plea of nolo contendere) or imposition of sentence, or both, by any judicial body charged with the responsibility to determine violations of the Federal or State criminal drug statutes; *Criminal drug statute* means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, use, or possession of any controlled substance; *Employee* means the employee of a grantee directly engaged in the performance of work under a grant, including:

(i)All direct charge employees;

(ii)All indirect charge employees unless their impact or involvement is insignificant to the performance of the grant; and,

(iii)Temporary personnel and consultants who are directly engaged in the performance of work under the grant and who are on the grantee's payroll. This definition does not include workers not on the payroll of the grantee (e.g., volunteers, even if used to meet a matching requirement; consultants or independent contractors not on the grantee's payroll; or employees of subrecipients or subcontractors in covered workplaces). Certification Regarding Drug-Free Workplace Requirements Alternate I. (Grantees Other Than Individuals) The grantee certifies that it will or will continue to provide a drug-free workplace by:

(b)Establishing an ongoing drug-free awareness program to inform employees about—

(1)The dangers of drug abuse in the workplace;

(2)The grantee's policy of maintaining a drug-free workplace;

(3)Any available drug counseling, rehabilitation, and employee assistance programs; and

(4)The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(c)Making it a requirement that each employee to be engaged in the performance of the grant be given a copy of the statement required by paragraph (a);

(d)Notifying the employee in the statement required by paragraph

(a)that, as a condition of employment under the grant, the employee will—

(1)Abide by the terms of the statement; and

(2)Notify the employer in writing of his or her conviction for a violation of a criminal drug statute occurring in the workplace no later than five calendar days after such conviction;

(f)Taking one of the following actions, within 30 calendar days of receiving notice under paragraph (d)(2), with respect to any employee who is so convicted —

(1)Taking appropriate personnel action against such an employee, up to and including termination, consistent with the requirements of the Rehabilitation Act of 1973, as amended; or

(g)Making a good faith effort to continue to maintain a drug-free workplace through implementation of paragraphs (a), (b), (c), (d),

(e)and (f).

(B)The grantee may insert in the space provided below the site(s) for the performance of work done in connection with the specific grant: Place of Performance (Street address, city, county, state, zip code) . Check if there are workplaces on file that are not identified here. Alternate II. (Grantees Who Are Individuals)

(FY)2008 to 2012. These proposed recommendations were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups. Section 505 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, enacted June 12, 2002, directs FDA to publish these proposed recommendations in the **Federal Register** ; hold a meeting at which the public may present its views on such recommendations; and provide for a period of 30 days for the public to provide written comments on such recommendations. DATES: The public meeting will be held on February 16, 2007, from 9 a.m. to 5 p.m. Submit written comments by February 23, 2007. Registration to attend the meeting must be received by February 2, 2007. ADDRESSES: The meeting will be held at the Grand Hyatt Washington at Washington Center, 1000 H St. NW., Washington, DC 20001. Located at the Metro Center metro stop. Follow 11th St. exit to the lobby of the Grand Hyatt. For additional directions, see the hotel Web site at: *http://grandwashington.hyatt.com/hyatt/hotels/* . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: For information regarding this document, contact: Ann Sullivan, Office of Policy and Planning (HFP-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5887, FAX: 301-827-5225, e-mail: *Ann.Sullivan@fda.hhs.gov* . For information regarding registration, contact: Bernadette Kawaley, Office of Communication, Training and Manufacturers Assistance (HFM-49), Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-2000, FAX: 301-827-3079. SUPPLEMENTARY INFORMATION: I. Introduction The Prescription Drug User Fee Act (PDUFA I), first enacted in 1992 (Public Law 102-571, October 29, 1992), authorized FDA to collect user fees from regulated industry that were to be dedicated to expediting the review of human drug applications in accordance with certain performance goals identified in letters from the Secretary of Health and Human Services to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate (138 Cong. Rec. H9099-H9100 (daily ed. September 22, 1992)). In 1997, as PDUFA I expired, Congress passed the Food and Drug Administration Modernization Act (FDAMA, Public Law 105-115). FDAMA included, among other things, an extension of PDUFA (PDUFA II) for an additional 5 years. In 2002, Congress extended PDUFA again for 5 years (PDUFA III) through the Public Health Security and Bioterrorism Preparedness and Response Act (Public Law 107-188). Before PDUFA, FDA's review process was more unpredictable, and slower. At the same time, regulators in other countries were able to review products faster. Access to new medicines for U.S. patients lagged behind. For example, a 1989 study by researchers at Tufts University, analyzing differences in the number of new drugs introduced and time to marketing in the United Kingdom compared to the United States for the period 1977 to 1987, found that the United Kingdom led the United States in the number of first introductions of new drugs (114 versus 41) and in the average lead time for mutually available drugs (60.7 months lead time in the United Kingdom versus 28.9 months in the United States) and in the number of exclusively available new drugs (70 versus 54). 1 In addition, a 1992 review of the international literature related to drug lag found that most studies reported the United States, Sweden and Norway to have a long delay in the introduction of new drugs, while the United Kingdom and

(West)Germany were generally found to have the shortest delay. 2 Chronic understaffing of drug review and related delays in U.S. patient access to new drugs led to the 1992 enactment of PDUFA. PDUFA provided FDA with added funds that enabled the agency to hire additional reviewers and support staff and upgrade its information technology systems to speed the application review process for new drugs and biological products without compromising FDA's high standards for approval. 1 Kaitin, K.I., N. Mattison, F.K. Northington, L. Lasagna, The drug lag: an update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987, *Clinical Pharmacology and Therapeutics* , 1989; 46 (2):121-38. 2 Andersson, F., The drug lag issue: the debate seen from an international perspective, *International Journal of Health Services* , 1992; 22(1): 53-72. Since the beginning of the PDUFA program, there has been a significant improvement in FDA funding for the drug review program, including significant investments in information technology. PDUFA has enabled FDA to virtually double the staff dedicated to the process of reviewing human drug applications since 1992. Under PDUFA, the industry provides additional funds through user fees that are available to FDA, in addition to appropriated funds, to spend on the human drug review process. Our authority to collect user fees is “triggered” only when a base amount of appropriated funds, adjusted for inflation, is spent. In conjunction with PDUFA, FDA set review performance goals that became more stringent each year. These goals applied to the review of original new human drug and biological product applications, resubmissions of original applications, and supplements to approved applications. During the first few years of PDUFA I, we eliminated backlogs of original applications and supplements that had formed in earlier years when the program had fewer resources. Phased in over the 5 years of PDUFA I, the goals were to review and act on 90 percent of priority new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements (i.e., submissions for products providing significant therapeutic gains) within 6 months of submission of a complete application; to review and act on 90 percent of nonpriority original NDAs, BLAs, and efficacy supplements within 12 months, and on resubmissions and manufacturing supplements within 6 months. Over the course of PDUFA I, we exceeded all of these performance goals. Under PDUFA II, some review performance goals continued to shorten. For example, by 2002, the PDUFA II goals called on us to review and act on 90 percent of the following: • Standard new drug and biological product applications and efficacy supplements within 10 months, • Chemistry and manufacturing control supplements requiring prior FDA approval within 4 months, and • Class 1 resubmissions (that respond to relatively minor deficiencies such as labeling changes) within 2 months. In addition, PDUFA II added a new set of goals intended to improve our interactions with industry sponsors during the early years of drug development, again with the goal of making promising new drug therapies available to patients sooner. For example, these procedural goals called for us to meet with sponsors and provide followup meeting minutes within a certain number of days, and provide responses to questions on industry submitted special study protocols within a certain number of days. For example, PDUFA II goals called for us to respond to 90 percent of industry requests: • Scheduling Type A meetings within 30-calendar days of FDA receipt of the meeting request, • Scheduling Type B meetings within 60-calendar days of FDA receipt of the meeting request, • Scheduling Type C meetings within 75-calendar days of FDA receipt of the meeting request, and • Completing written assessments of the adequacy of special protocols within 45 days of sponsor requests. However, the agency experienced a much heavier review workload than was accounted for by PDUFA II fee funding. By the end of PDUFA II, the program was beginning to falter in terms of both performance and financial stability. Although we were able to meet the letter of the performance deadlines in many cases, FDA reviewers were not able to allocate time for earlier and more frequent communication and feedback to sponsors that might have resulted in better-quality applications and a higher rate of first-cycle approvals. Under the current program, reauthorized in 2002 (PDUFA III), additional money from user fees was authorized to better finance the expanded scope and growing volume of demand for FDA review and consultation, and a mechanism was placed in PDUFA to annually adjust fee revenues for increases in workload associated with the process for the review of human drugs. For the first time, PDUFA III also authorized FDA to spend user fee funds on certain aspects of postmarket risk management. The review performance and procedural goals associated with PDUFA III were similar to those under PDUFA II for FY 2002 performance levels, but the PDUFA III program addressed drug safety issues and established several new initiatives to improve application submissions and agency-sponsor interactions during drug development and application review. The goals under PDUFA III included new provisions, for example, to develop guidance for industry on good risk assessment, risk management, and pharmacovigilance practices; to fund outside expert consultants to help evaluate and improve review management processes; and to centralize accountability and funding for all PDUFA information technology initiatives and activities. Furthermore, in conjunction with PDUFA's reauthorization in 2002, FDA set the goal of creating a guidance for our review staff and industry on good review management principles and practices (GRMPs) as they apply to the first cycle review of NDAs, BLAs, and efficacy supplements. We also set a goal of evaluating whether providing early review of selected applications and additional feedback and advice to sponsors during drug development for selected products can shorten drug development and review times. Two “continuous marketing application”

(CMA)pilot programs were initiated. CMA Pilot 1 provides for the review of a limited number of presubmitted portions of NDAs and BLAs. Under CMA Pilot 2, FDA and applicants can enter into agreements to engage in frequent scientific feedback and interactions during the investigational new drug phase of product development. When it enacted PDUFA III, Congress enacted special provisions regarding public accountability in the development of recommendations for PDUFA IV. Congress directed FDA, when developing recommendations to the Congress for PDFUA IV, to “consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry” (Section 505. Accountability and Reports). In preparing our proposed recommendations for PDUFA reauthorization, we have conducted technical discussions with regulated industry and have consulted with stakeholders as required by law. We began our public consultation on PDUFA reauthorization with a public meeting held on November 14, 2005 ( *http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20875.htm* ). The meeting included presentations by FDA and a series of panels representing different stakeholder groups, including patient advocates, consumer groups, regulated industry, health professionals and academic researchers. The stakeholders were asked to respond to the following questions:

(1)What is your assessment of the overall performance of the PDUFA program thus far and

(2)What aspects of PDUFA should be retained, or what should be changed, to further strengthen and improve the program? There was general agreement among the responding stakeholders that PDUFA should be reauthorized. Most expressed the view that drug review should not only include safety and effectiveness review prior to marketing approval, but also should encompass continued safety monitoring after approval. Many panelists supported increased PDUFA funds for postmarket drug safety surveillance, including developing and monitoring risk management tools. A number of panelists also expressed support for increased resources to fund the review of direct-to-consumer

(DTC)advertising. Some panelists expressed concern that over-emphasizing safety might delay patient access to new treatments, and some expressed support for PDUFA funding of “Critical Path” projects to help speed new drug development (see *http://www.fda.gov/oc/initiatives/criticalpath/* ). In addition to our initial public meeting in November 2005, we held followup meetings to obtain further input on the PDUFA program and suggestions regarding what features should be proposed or amended with program reauthorization. On May 22, 2006, we held a meeting with patient advocacy groups. Overall, these groups supported reauthorization of PDUFA as a vehicle for speeding patient access to safe and effective drug therapies. They also suggested that user fees be increased to sufficiently fund postmarket safety activities and that the issues raised in the March 2006 GAO report entitled, “ *Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process* ” (GAO-06-402) *http://www.gao.gov/new.items/d06402.pdf* report on drug safety be addressed. In addition, it was suggested that FDA establish postmarket performance goals, such as milestones for development of a better postmarket safety system. On May 23, 2006, FDA held a meeting with consumer advocacy groups to get their input on PDUFA reauthorization. Some consumer groups indicated a preference for full funding of human drug review with appropriated funds rather than user fees, but they generally considered fee-funding to be inevitable and PDUFA reauthorization to be necessary. Given this, the consumer advocacy groups who participated in the meeting emphasized that user fees should be used to enable the agency to adequately cover its priorities, but there should be no ties between user fees and performance goals. They also expressed the view that appropriated funding should be increased and there should be increased funding to enhance FDA's capacity for postmarket safety and DTC advertising review. Some consumer advocates further suggested that FDA charge separate fees for DTC advertising review. On June 23, 2006, we held a meeting with health professional groups to obtain their views and suggestions for reauthorization. The health professional groups supported PDUFA reauthorization to maintain an efficient process and the availability of safe and effective new drugs on the market. They also thought sufficient funding was needed to maintain a competent scientific staff. The health professional groups thought PDUFA fees should be increased to support safety surveillance and risk management, and the current statutory time period for using fee funds for safety-related work should be eliminated or expanded. They also felt that fee-funded support for risk management plans should be expanded to include older drugs as well as those recently approved. They indicated that the issues raised in the March 2006 GAO report on drug safety needed to be addressed. Finally, they suggested that PDUFA funds be increased to support the review of DTC advertising. Congress also directed FDA to publish in the **Federal Register** the proposed recommendations developed through this process after negotiations with the regulated industry, present the proposed recommendations to the congressional committees specified in the statute, hold a public meeting at which the public can present its views on the proposed recommendations, and provide for a period of 30 days for the public to provide written comment on the proposed recommendations. We have now concluded discussions with industry and other stakeholders regarding reauthorization of PDUFA. The purpose of this document is to publish the recommendations we intend to propose to Congress and announce the dates for the upcoming public meeting and written comment period. After the public meeting and the close of the 30-day comment period, we plan to undertake a careful review of all public comments on these proposed recommendations. II. What We Are Proposing to Recommend for PDUFA IV For PDUFA IV, as described in the following paragraphs, we plan, with a few exceptions, to carry forward the performance goals from PDUFA III and we propose additional goals related to proposed enhancements to the program. Our proposed recommendations fall into three major categories:

(1)Proposals to ensure sound financial footing for the human drug review program;

(2)proposals to enhance the process for premarket review of human drug applications; and

(3)proposals to modernize and transform the postmarket safety system. In addition, we are proposing to recommend a program separate from, but related to, PDUFA pertaining to fees assessed for advisory reviews of DTC television advertisements. The summary table containing the proposals and related fees under PDUFA IV can be found in table 1 of this document. The discussion and additional fee estimates in this section

(II)and table 1 of this document, do not include our proposals and proposed fee revenue figures for review of DTC television advertisements. Those proposals are provided in section III of this document. **Table 1.— PDUFA IV Financial Baseline and Enhancements (starting in FY 2008)** Financial Baseline Dollars FTE FY 2007 Baseline—Adjusted for Inflation $305,455,400 1539 Inflation Adjustment for FY 2008 $17,716,600 Adjustment for Increased Rent and Rent-Related Costs $11,721,000 Adjustment for Increased Work per IND & NDA PDUFA III $20,000,000 87 PDUFA IV Baseline Before Enhancements $354,893,000 1626 Enhancements Premarket—Expediting Drug Development $4,600,000 20 Premarket—Improving IT Infrastructure for Drug Review $4,000,000 Postmarket—Modernizing and Transforming Safety System $29,290,000 82 PDUFA IV Total 1 (in FY 2008) $392,783,000 1728 1 Further workload adjustment, to account for work levels in FY 2007, is expected to add about $45,000,000 and 195 FTEs for a final total of about $437,800,000 and 1923 FTEs for FY 2008. A. Proposed Recommendations to Ensure Sound Financial Footing Although user fees have provided substantial resources to FDA since the beginning of the program, user fees have not kept up with the increasing costs of the program associated with inflation in pay and benefit costs to the agency, rent and rent-related costs, and workload. Although the current law contains provisions for adjusting fees to reflect the rate of inflation and changes in workload, we found that the statutorily prescribed method for adjusting fees has not adequately accounted for actual growth in costs and workload during PDUFA III. We are proposing changes to the financial provisions of PDUFA to correct for the shortcomings in these adjustment factors and place FDA on a sound financial footing so we can continue with the program and make enhancements to it. 1. Adjustment of Base Fee Revenue Amount for Growth in Cost and Workload Section 736(b) of the PDUFA provides the basic target fee revenue amounts FDA uses to establish the application, product, and establishment user fees each year. These target fee revenue amounts are then adjusted for inflation and increases in workload, and the resulting number becomes the amount FDA is authorized to collect in fees. The statutory fee revenue amount for FY 2007 was $259,000,000. Adjusted for inflation in accordance with PDUFA, that amount became $305,455,400 for FY 2007. However, the PDUFA IV program will not begin until FY 2008, so it was necessary to further adjust this number to obtain the appropriate target revenues for FY 2008 before any adjustments are made. FDA's proposed recommendation to Congress resulting from industry discussions is that the base target revenue estimate for FY 2008 should be $392,783,000 and that this estimate should be further adjusted for workload for FY 2007. FDA would calculate the workload adjustment based on submissions through June 30, 2007, and publish the final amount and supporting calculations when fees for FY 2008 are published. The proposed target revenue estimate for FY 2008 includes the following components: • The base revenue amount authorized in the current statute for FY 2007, adjusted for inflation using provisions of the current statute. This amount is $305,455,400. • An addition of $17,716,600 to adjust the base amount for inflation for FY 2008. We assume a continuation of the average FDA payroll and benefit cost inflation of 5.8 percent per year (see the Inflation Adjustment discussion in section II.A.2.a of this document). • An addition of $11,721,000 to ensure that fees cover a proportionate share of the increased costs that FDA will have to pay for rent and rent-related costs and one-time costs of the required move to the White Oak facility in Silver Spring, MD. These costs would be added to the fee total to maintain the needed level of review staffing (and associated direct costs) while also paying for these critical nondiscretionary operating costs. • An addition of $20,000,000 to adjust the base amount of fee revenues to cover significant increases in FDA's drug review workload that occurred during PDUFA III, but were not captured by the workload adjustment provision of PDUFA III and which we are recommending be revised for PDUFA IV (see the Workload Adjustment discussion in section II.A.2.b of this document). The PDUFA III workload adjuster captured workload increases associated with increased numbers of submissions, but did not capture workload increases associated with the increased level of effort for each submission. FDA documented that the review effort for each submission increased significantly during PDUFA III. The investigational new drug workload increased markedly because of significantly more meetings per investigational new drug

(IND)submitted and because of a sharp increase in the number of special protocol assessments submitted for FDA review. • An addition of $37,890,000 to fund the proposed enhancements to the PDUFA program, including enhancements to the premarket review program and proposals for modernizing and transforming the postmarket safety system. The sum of these components yields the proposed target revenue figure of $392,783,000. ($392,883,000 = $305,455,400 + $17,716,600 + $11,721,000 + $20,000,000 + $37,890,000). 2. Proposed Revisions to the Inflation Adjustment and Workload Adjustment Applied to User Fees

(a)*Inflation Adjustment* : The fee revenue amounts for PDUFA III were stated in FY 2003 dollars and the proposed fee revenue amounts for PDUFA IV are stated in FY 2008 dollars. Before fees were assessed each year in PDUFA III, the fee revenue target was increased and compounded based on the higher of either:

(1)The CPI/U over the latest 12-month period or

(2)the most recent increase in pay for Federal employees in the Washington, D.C. area, compounded since FY 2003. The rate of pay for employees in the Washington D.C. area was higher in all but one year, and the PDUFA III inflation adjustment has resulted in average annual inflation increases of 4.16 percent over each of the last 5 years. However, the actual cost of pay and benefits per full time equivalent

(FTE)is increasing faster than this factor. Data from the past 5 years shows that the actual cost of salary and benefits has increased at an average rate of 5.8 percent per year during the past 5 years for FDA. FDA proposes to recommend changing the provision for calculation of the inflation adjustment to add to it a third factor—FDA's actual rate of increase in the costs of pay and benefits per FTE during the most recent 5-year period—and the annual adjustment would be based on the highest of the three factors each year.

(b)*Workload Adjustment* : The workload adjuster currently applied in PDUFA makes adjustments for changes in numbers of applications, but it is flawed in two ways. First, the surrogate for IND workload in the current workload adjuster is the number of new commercial INDs submitted each year. Since each one of these INDs is active for several years, the number of new applications submitted in any 1 year is a poor surrogate for total IND workload. Second, the workload adjuster does not take into account increases in work associated with active INDs, NDAs, and BLAs. During PDUFA, there has been a substantial increase in the numbers of meetings and special protocol assessments per IND submission. However, the current workload adjuster only takes into consideration changes in numbers of submissions—not additional activity required per submission. Since FY 2002, the number of meetings per commercial IND has increased by close to 30 percent, and the number of special protocol assessments is up over 90 percent. This same phenomenon occurs with NDAs as well, but to a somewhat lesser extent. To remedy these flaws, the following changes are proposed: First, we recommend changing the surrogate for IND workload in the statute from the numbers of new commercial INDs received each year to the total number of active commercial INDs each year. Active INDs are those that have had at least one submission in the previous 12-month period. Second, we recommend using an adjuster applied to the numbers of NDA/BLAs and INDs. The proposed adjuster would adjust the numbers of these applications in proportion to the impact on workload of increased meetings and special protocol adjustments for INDs and for increased meetings, labeling supplements, and annual reports for NDAs and BLAs. Under the proposed change to the workload adjuster, we also propose to contract with an independent accounting firm to examine the new adjuster and make recommendations, if needed, for further improving this adjuster. 3. Technical Changes to Increase Administrative Efficiency of the User Fee Program The FDA is proposing to recommend several technical changes to PDUFA to simplify some of FDA's current procedures, to clarify the original intent of several PDUFA definitions, and to remove potential ambiguity. FDA's analysis of the impact of these changes indicates that they would be revenue-neutral and would have a minimal impact on industry fee-payers. These technical proposals include the following:

(a)Simplify the definition of “human drug application” to include all new drug applications under section 505(b) of the Federal Food, Drug, and Cosmetic Act;

(b)Amend the definition of “small business” for the purpose of fee collection to reinstate language from the original PDUFA statute that specifies that to qualify as a small business, the company may not have an approved product already introduced in or delivered for introduction into interstate commerce;

(c)Include capsules, tablets, and lyophilized products as examples in the definition of final dosage form to provide clarification of what constitutes a finished dosage form;

(d)Revise the waiver provisions to clarify that the person named as the applicant and assessed the user fee is the person who is eligible to request a waiver or reduction of fees;

(e)Change the date for the calculation of the adjustment factor so it can be calculated before the President's budget goes to Congress;

(f)Clarify that for fee purposes, applications withdrawn before filing will be treated as applications that FDA refuses to file, and that they will be assessed a full fee if filed again or filed over protest;

(g)For user fee purposes, reinstate the definition of “person” to include affiliates, as enacted under FDAMA

(h)Delay offsets for collections in excess of appropriations in any year to the final year of the PDUFA program and make offsetting reductions only if cumulative fees collected over the first 4 years exceed cumulative appropriations for fees over the same period; and

(i)Revise the definition of “prescription drug product” for the purpose of fee collection, to clarify the exclusion of products on discontinued product lists maintained by Center for Drug Evaluation and Research

(CDER)and Center for Biologics Evaluation and Research (CBER). B. Enhancing the Process for Premarket Review In the premarket review area, several changes were made in PDUFA III as compared to PDUFA II. These are outlined as follows: • *Continuous marketing application pilot programs* : Two pilot programs were established under PDUFA III to test whether providing early review of selected applications and additional feedback and advice to sponsors during drug development for selected products can further shorten drug development and review times. Pilot 1 involved a commitment on the part of FDA to review and provide feedback to the sponsor within 6 months of submission of “reviewable units” of an application in advance of the submission of the complete application. This pilot program represented an extension of the “rolling review” program begun under FDAMA and was limited to applications that had received a Fast Track designation. Pilot 2 involved a commitment on the part of FDA to provide more structured and extensive interaction and feedback to sponsors for up to one Fast Track application per review division during drug development. This pilot represented an extension of the usual interactions between FDA and sponsors during drug development. To evaluate the costs and benefits of these pilots, FDA commissioned an independent assessment. The CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies—Final Report is available on the FDA Web site at *http://www.fda.gov/ope/CMA/CMAFinalReport.pdf* . After review of the findings, FDA and industry representatives have agreed that although the pilots demonstrated value in some areas, the overall added benefits of the programs did not justify their costs to FDA. Therefore, FDA is proposing to recommend that the CMA pilot programs will not be continued in PDUFA IV. • *First cycle review performance* : In PDUFA III, FDA committed to several new goals that were focused on improving the effectiveness and efficiency of first cycle reviews in an attempt to decrease the number of multi-cycle reviews without compromising FDA's traditional high standards for approval. The first new goal was for FDA to notify the applicant of any substantive deficiencies identified in an application during the initial filing review. The identification of such deficiencies was to be communicated to the applicant within 14 days of the 60-day application filing date, which is commonly known as a “74 day letter.” FDA has consistently met or exceeded the goals for communication of these early deficiencies. The second new goal was for FDA to develop and publish a final joint CDER/CBER guidance on GRMPs. FDA published a final GRMP final guidance on March 30, 2005, entitled, “ *Guidance for Review Staff and Industry on Good Review Management Principles and Practices for Prescription Drug User Fee Act Products; Availability,* ” at *http://www.fda.gov/OHRMS/DOCKETS/98fr/05-6404.htm* (70 FR 16507; March 31, 2005). As part of the goals, FDA also committed to develop and implement a training program for all CDER and CBER review staff on the GRMPs. FDA met the goal for training all review staff on the GRMPs and has incorporated training on the guidance as part of new reviewer training. Finally, FDA committed to commission an independent consultant evaluation of the factors associated with the conduct of first cycle reviews. The first study was a retrospective analysis of first cycle reviews for NME and original BLAs submitted in FY2002-2004, and is available on the FDA Web site at *http://www.fda.gov/ope/pdufa/PDUFA1stCycle/pdufa1stcycle.pdf* . The second study was a prospective study of first cycle reviews for NME and original BLA submissions starting in FY05 and continuing through FY07, and is currently in progress. FDA is proposing to recommend the continuation of first cycle review performance initiatives. • *Independent consultants for biotechnology clinical trial protocols* : This initiative allowed applicants for certain biotechnology products to request that FDA engage an independent expert consultant, selected by FDA, to participate in the agency's review of the protocol for clinical studies that were expected to serve as the primary basis for a claim. FDA has received no requests under this initiative during PDUFA III and, after discussions with industry representatives, FDA is proposing not to include this initiative in the recommended PDUFA IV program. 1. Proposed Recommendations for Enhancement of Premarket Review Process In the area of premarket review, FDA is proposing to recommend enhancements in two areas:

(1)Good review management principles and

(2)expediting drug development.

(a)*Expanding Implementation of GRMPs* : In the area of GRMPs, we are proposing to recommend further enhancements associated with notifying applicants at the time of the “74-day letter” of the anticipated timeline for review of the application, including the anticipated date for initiation of discussions regarding product labeling and any FDA requests for postmarketing study commitments (PMCs). Historically, labeling discussions have been initiated at the late stages of a review, often in the last week before approval. Similarly, the agency often communicates requests for postmarketing commitments late in the review cycle. Initiation of discussion of these important elements of the review of an application late in the review cycle is often due to the inability of FDA to complete its review of the application earlier because of an imbalance between workload and available review staff time. Late initiation of these important discussions is not consistent with the best practices that FDA has identified and published in the GRMP guidance. An understanding on the part of both the reviewers and the applicant of the process and timeline for the review would facilitate an efficient and scientifically sound review. FDA believes that adhering to a timeline that includes earlier initiation of discussion of labeling, coupled with the new physician labeling regulations (see *Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products* at *http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf* ) (71 FR 3922, January 24, 2006), would result in clearer, more readily understandable labeling for new products. Furthermore, FDA believes that initiation of discussions of possible postmarketing commitments earlier in the process would allow for the commitments to be more focused on the data needed to further inform the best use of the products. We also expect that earlier discussion of PMCs would help to ensure that the agreed to studies and study schedules are feasible, thereby improving the timely completion of the studies by the applicant. The proposed recommendations under the enhancements for GRMP are also intended to encourage applicants to provide FDA with applications that are complete for review at the time of submission. The submission of complete applications would allow FDA to effectively manage and adhere to its review schedule and, ultimately, may result in faster access to these new products without any compromise to FDA's traditional high standards for approval. Consequently, FDA believes these proposed recommendations to be in the best interest of the agency, the applicant, and, ultimately, the public health.

(b)*Expediting drug development* : One of the things that the agency can do to enhance the development of new and beneficial drugs is to provide guidance to industry to clarify current agency thinking on a variety of topics including, among other things, clinical trial design. Our experience and insight, gained through years of review, can help the industry avoid wasting scarce research and development resources on clinical trials that are not likely to produce results because of flawed designs. By clarifying the agency's expectations regarding the nature of data needed to support certain types of claims, we can allow the industry to focus their efforts on useful trials and decrease less useful experimentation. This would have the benefit of decreasing exposure of subjects to unapproved products, decreasing the amount of time required to bring a beneficial new drug to market, and, possibly, decreasing the total cost of bringing the new drug to market, which should translate to lower drug prices for the consumer. Guidance development by the agency requires substantial time commitments from those who are already heavily involved in the review effort. The PDUFA IV proposal includes increased user fees that would be used to fund additional staff resources to develop the following guidances to enhance clinical drug development (the FY dates for each guidance represent FDA's proposed commitment to publish a draft guidance on that topic by no later than the end of FY listed): 1. Clinical Hepatotoxicity—FY 2008. This guidance would address how to evaluate a drug for possible hepatotoxicity during drug development and how FDA will review an application to look for signs that a drug may be a significant hepatotoxin. 2. Non-inferiority Trials—FY 2008. This guidance would describe FDA's perspective on the design of noninferiority trials. Topics addressed are expected to include how to select the active control, how to document the effect size of the active control versus placebo, and how to establish the noninferiority margin of interest. 3. Adaptive Trial Designs—FY 2008. This guidance would explain FDA's perspective on the use of adaptive trial designs during drug development. Topics to be addressed include the definition of adaptive trial designs, recommended designs, and how the statistical issues should be addressed in analyzing trials. 4. End of Phase 2(a) Meetings—FY 2008. This guidance would outline the procedures and data needed for an end-of-phase 2a (EOP2a) meeting. The EOP2a meetings are intended to facilitate FDA interactions with a sponsor earlier in the design of the development program to maximize the value of the phase 2 program with the overall goal of making drug development more efficient and effective. 5. Multiple Endpoints in Clinical Trials—FY 2009. This guidance would describe FDA's perspective on the appropriate procedures and analyses for trials with multiple endpoints (e.g., a trial with multiple co-primary endpoints). 6. Enriched Trial Designs—FY 2010. This guidance would focus on approaches to enrich the clinical trial population to better define the efficacy or safety of the drug under development. 7. Imaging Standards for Use as an End Point in Clinical Trials— FY 2011. This guidance would focus on the use of images as important endpoints in controlled clinical trials. Issues would include image acquisition, archiving, and blinded reading. The commitment, under this part of the proposed PDUFA IV program, would allow us to pursue the development and publication of several guidance documents to facilitate the development of new, life-saving therapies, moving them more efficiently from the laboratory to the bedside. In addition to funding the development of guidances, under PDUFA IV we are proposing to collect user fees to hire additional staff to free up reviewer time to enable greater participation in scientific research collaborations that will ultimately help clarify regulatory pathways for new technologies and potential new biomarkers for drug safety and effectiveness. For example, FDA intends to participate in workshops with representatives from the scientific community (including industry, academia, and other interested stakeholders) to further the science toward development of guidance documents in the following areas: 1. Predictive toxicology—Emerging science such as toxicogenomics, proteomics, metabolomics, and molecular imaging, is expected to yield more sensitive, specific, and informative tests for drug organ toxicity than the toxicology screening techniques currently in use. FDA reviewers will need to participate extensively in the design of studies intended to qualify these new safety tests for regulatory uses. 2. Biomarker Qualification—Biomarkers are frequently used during drug development to understand the effect of a drug on biologic systems and to predict clinical response. Before biomarkers can be used for regulatory decision making they must be qualified. FDA expertise will be needed on an ongoing basis in the effort to select and test candidate biomarkers for qualification. FDA reviewers will need to participate in the design of the definitive studies intended to qualify the biomarker for a specific regulatory use. 3. Missing Data—In controlled clinical trials it is often impossible to ensure that every data element described in the protocol is collected for every study subject. For example, subjects often discontinue participation in a trial early and do not return for further study visits. The question of how to handle missing data when analyzing the results of a trial is a very complex one, and FDA would expect to work in collaboration with outside stakeholders to further explore the science of this issue and develop appropriate procedures. Finally, under the proposal for PDUFA IV, user fees would be used to support FDA participation in workshops and other public meetings to explore new approaches to a structured model for benefit/risk assessment. The results of these interactions would be used to assess whether pilot(s) of such new approaches can be conducted during PDUFA IV. These efforts may lead to the development of guidance documents. Under PDUFA IV, FDA proposes to collect an additional $4,600,000 in FY 2008 and, in subsequent years, adjusted for inflation and workload, to support at least 20 FTEs to engage in the collaborations with outside stakeholders described previously. 2. Improving the IT Infrastructure for Human Drug Review Under PDUFA III, we agreed to certain performance goals associated with better management of information technology

(IT)resources and improved consistency of IT practices across the human drug review program. Under PDUFA III, we centralized accountability for PDUFA IT funding under the Chief Information Officer (CIO); established an IT Project Management Office to develop and implement processes policies, based on the Capability Maturity Model Integration process improvement approach to improve software development practices; implemented the electronic Common Technical Document standard for electronic regulatory submissions; established a common secure single point of entry for the receipt and processing of all electronic submissions, commonly called the FDA Electronic Submissions Gateway; and established a common approach to managing desktop hardware and software configurations. We are now in the process of establishing a common approach for secure e-mail that will be implemented throughout the PDUFA program. Following provisions in the PDUFA III commitment letter, we have also met quarterly with industry representatives to discuss progress towards these IT goals and to address technical implementation issues. These accomplishments have built a strong foundation for further progress toward an IT environment that better serves the human drug review program. Under PDUFA IV, we recommend collection of an additional $4,000,000 annually, starting in FY 2008 to enable the agency to commit to several IT performance goals that would move FDA and industry towards an all-electronic environment, which would increase the efficiency of the review process. Under these proposed goals, we would commit to develop a 5-year IT plan that would lay out the technical approach for achieving a more integrated, standards-based electronic regulatory submission and review environment. The plan would help FDA, industry, and stakeholders make related IT investments in a more coordinated manner. By the end of PDUFA IV, following implementation of these proposed goals, human drug application sponsors would be able to send in their electronic applications with automated cross-links to previously submitted data and information, so that they only have to submit things once. In addition, FDA reviewers would be able to retrieve all relevant submissions and related data electronically from their work stations and would have efficient tools for searching and analyzing data to support their reviews. These capabilities would enable more efficient and reliable management of regulatory submissions. By the end of PDUFA IV, if resources are provided as expected, we intend to have the capability to handle two-way transmission of regulatory correspondence with industry, which would accelerate the movement toward an all-electronic submission and review environment. To determine whether we are moving towards achieving the IT goals described in PDUFA IV, we further propose to track several key performance indicators of the adoption rate of electronic submissions and the technical error rates associated with those submissions, so that we can more closely monitor progress toward the all-electronic environment. Finally, in the recommended IT performance goals for PDUFA IV, we propose a cost-effective approach that minimizes expenditures on existing legacy systems and redirects those funds toward the development of new common systems that are better coordinated and more flexible. C. Modernizing and Transforming the Postmarket Drug Safety System In PDUFA III, for the first time, FDA was authorized to spend user fees revenues to fund improvements in drug safety. This change provided important new resources to help improve postmarket safety but our experience has shown that further improvements can be achieved. The definition of the “process for the review of human drug applications” in section 735 of PDUFA describes which products PDUFA funds can be used for in terms of postmarket safety review as well as the length of time after product approval PDUFA funds can be used for such safety review. Specifically, 735(6)(F) states: “In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.” In addition, the PDUFA III Reauthorization Performance Goals and Procedures document stated that user fees may be used “for a period of up to two years post-approval for most products and for a period of up to three years for products that require risk management beyond standard labeling * * *.” The stated purpose of this language was to provide user fees to review an applicant's implementation of risk management plans for this period of time and to allow for evaluation of study reports, product use, and other safety activities. Drug safety activities outside of the specified timeframe were to be funded with appropriated dollars. As part of the PDUFA IV program, we propose to recommend further enhancing the program by removing the language that limits the spending of user fees outside of the specified timeframe. Current data show that safety issues can arise after a drug has been on the market for 8 or more years. A recent FDA analysis of safety-related label changes made between October 2002 and August 2005, for all drug products with a labeling change, found that the total number of safety-related label changes exceeded 160 changes for drugs 3 years postapproval and remained at or above that high level until 8 years postapproval before starting to decline. All stakeholders agree that the current limitations on use of funds for postmarketing safety-related activities present an opportunity for improving the agency's ability to optimally support adverse event surveillance, detection, evaluation, and management. Enhancing the program by eliminating such limitations would help both FDA and drug sponsors because safety assessments of drug products by both FDA and sponsors are necessary for drugs over time to adequately manage risks, regardless of approval date. Increased resources, including from PDUFA funds, would enable FDA to engage in safety review activities, such as studies of drugs in the same class approved before and after October 1, 2002, to adequately assess significant drug safety issues. The current description of postmarketing safety activities in the definition of the “process for the review of human drug applications” could also be revised to better reflect the broad variety of activities that are important to postmarket safety review. As part of the reauthorization of PDUFA, FDA proposes changing the statute to eliminate the statutory restrictions so that PDUFA fees could be used to assess safety issues postapproval, independent of a product's approval date and would allow the agency to review the drug's safety in whatever time frame risks arise using all available resources. This change would provide much needed support for timely, predictable, consistent, and scientifically sound regulatory decisionmaking and would work towards a fully integrated evaluation of drugs and biologics throughout their life cycle. In addition, we propose expanding the description of postmarket safety activities to capture a broader range of activities related to postmarket safety review. For example, FDA would use $29,290,000 in new user fee funds to enhance and modernize the current U.S. drug safety system. We would adopt new scientific approaches, improve the utility of existing tools for the detection, evaluation, prevention, and mitigation of adverse events associated with drugs and biological products. In addition, FDA would use these funds to continue to enhance and improve communication and coordination between pre- and postmarket review staff. Potential activities in this area might include integration of certain proposed recommendations made by the Institute of Medicine

(IOM)in their September 2006 report entitled, “ *The Future of Drug Safety: Promoting and Protecting the Health of the Public* .” PDUFA IV funds would also be used to support a number of activities designed to modernize the process of pharmacovigilance. One key initiative would be the implementation of an FDA contract to one or more outside research organization(s) to conduct research on determining the best way to maximize the public health benefits associated with collecting and reporting serious and nonserious adverse events occurring throughout a product's life cycle. Studies under this contract would answer such central questions as the number and types of safety concerns that are discovered by various types of adverse event collection, the age of the medical products at the time such safety concerns are detected, and the types of actions that are subsequently taken and their ultimate effect on patient safety. PDUFA IV funds would also support the development of a guidance document to delineate epidemiology best practices. Epidemiologic studies using large automated databases are increasingly being performed to evaluate drug safety. These studies and safety analyses are complex and employ a variety of nonstandardized analytic methods and assumptions. During the course of PDUFA IV, FDA, with input from academia, industry, and others from the general public, would hold a public workshop to identify best practices in this emerging field, ultimately developing a document that addresses epidemiology best practices and provides guidance on how to carry out scientifically sound observational studies using quality data resources. Another critical part of the transformation of the drug safety program would be maximizing the usefulness of tools used for adverse event detection and risk assessment. To achieve this end, data other than spontaneous adverse event reports, including population-based epidemiological data and other types of observational data resources, would be used and evaluated. Access to these types of data would expand our capability to carry out targeted postmarketing surveillance, look at class effects of drugs, and potentially carry out signal detection using data resources other than reports from FDA's adverse event reporting system (AERS). PDUFA IV funds would be used to obtain access to additional databases and increase program staffing with epidemiologists, safety evaluators, and programmers who can use these new resources. As mentioned previously, the PDUFA III Reauthorization Performance Goals and Procedures document provided user fees to review implementation of a risk management plans for a limited period of time and to allow for evaluation of study reports, product use, and other safety activities. Risk communication and management have now become a routine part of human drug review, yet many of the risk management and risk communication tools the industry uses remain unproven and unstandardized. To promote more effective and consistent use of these tools to mitigate the risk of drugs and biological products, under PDUFA IV, with input from academia, industry, and others from the general public, we would conduct an annual systematic public discussion and review of the effectiveness of one to two risk management programs and one major risk management tool per year. Reports from these discussions would be posted on the FDA Web site. FDA would also use PDUFA IV fees to enhance the agency's AERS and surveillance tools, to strengthen its IT infrastructure to support access and analyses of externally linked databases, and to support a safety workflow tracking system. This support for drug and biological product safety-related IT systems is critical to ensure the best collection, evaluation, and management of the vast quantity of safety data received by FDA. FDA would use PDUFA IV funds to develop and periodically update a 5-year plan describing the range of activities designed to enhance and modernize the drug safety system. FDA would publish and seek public comment on an initial plan for these activities and conduct an annual assessment of progress against the plan to be published on FDA Web site. In addition to progress against the specific modernization activities described previously, the annual report would include an update on FDA efforts to facilitate the interactions between the Office of New Drugs and the Office of Surveillance and Epidemiology related to the process of evaluating and responding to postmarketing drugs safety/adverse event reports. FDA would publish updates to the modernization plan as FDA deems necessary and post on FDA's Web site draft revisions to the plan, soliciting comments from the public on those draft revisions and then carefully considering all public comments before completing and publishing updates to the plan. Another recent study by the IOM, entitled “ *Preventing Medication Errors: Quality Chasm Series* ,” (July 20, 2006), estimates that, on average, every hospitalized patient is subject to at least one medication error per day. These errors lead to costly morbidity and mortality. The IOM concluded that drug names that look or sound similar, in addition to the layout and presentation of important drug information on the label, labeling, and packaging of drug products increase the risk of medication errors. The IOM report recommended that the FDA, the pharmaceutical industry, and other stakeholders should collaborate in several areas to improve methods for naming and labeling drug products and communicating medication information to providers and consumers and advised the FDA to develop guidance documents for industry related to drug naming, labeling, and packaging. Using PDUFA IV funds, FDA would implement various measures to reduce medication errors related to look-alike and sound-alike proprietary names as well as factors such as unclear label abbreviations, acronyms, dose designations, and error-prone label and packaging designs. Activities to be funded include guidance development, review performance goals, and initiation of a pilot program to explore a different paradigm for proprietary name review. Fees would provide the resources FDA needs to publish three guidances to industry:

(1)Guidance on the contents of a complete submission package for a proposed proprietary drug/biological product name;

(2)guidance on best practices for naming, labeling, and packaging drugs and biologics to reduce medication errors; and

(3)guidance on proprietary name evaluation best practices. These guidances, developed after consultation with industry, academia, and others from the general public, would provide a scientifically sound and consistent approach to the selection, evaluation, and review of proprietary names and would also create a framework for best practices for the layout and design of drug labels and packaging to prevent or minimize medication errors. In addition, under the proposed PDUFA IV program, FDA would commit to a performance goal of 180 days for reviewing proprietary names submitted during the IND and NDA phases. For submissions received as part of an IND, submitted as early as the end of phase 2 of drug development, FDA would increase the percentage of submissions subject to this goal, from 50 percent in year 1 to 90 percent in year 4 of the program. In a similar phased-in fashion, for submissions received as part of an NDA or BLA, FDA would review 50 percent (in year 1) increasing to 90 percent (in year 4) of proprietary name submissions within 90 days of receipt. Commitment to review goals would enhance the timeliness and predictability of proprietary name review. During PDUFA IV, FDA proposes to develop and implement a pilot program that shifts the responsibility for testing proposed proprietary names from FDA to the pharmaceutical industry. This program would enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review prior to approval. Using this more traditional FDA review role was recommended by the IOM in November 1999 report, entitled “ *To Err Is Human: Building a Safer Health System* , ” as well as the HHS Advisory Committee on Regulatory Reform in November of 2002 Secretary's Advisory Committee on Regulatory Reform, November 21, 2002, *http://regreform.hhs.gov/meetinginfo/november_meetinginfo.htm* . The proposed pilot would allow this approach to be evaluated for its contribution to the efficiency and timeliness of proprietary name review. III. What We Are Proposing to Recommend for Review of Direct-To-Consumer Advertising In addition to our proposed recommendations for enhancements to the current human drug review program, we are proposing to recommend a program separate from, but related to, PFUFA assessing fees for advisory reviews of DTC television advertisements. Research has shown there can be benefits associated with DTC prescription drug television advertising, such as informing patients about the availability of new treatment options and encouraging patients to see a physician about an illness for the first time. Notwithstanding these benefits, concerns have arisen about the effects of DTC television advertisements on prescribing practices and prescription drug use. Companies have the option of submitting their proposed advertisements to FDA for advisory review before publicly disseminating them, which gives them with the benefit of FDA input on whether or not the advertisements are accurate, balanced, and adequately supported, enabling them to address any problems before the advertisements are shown to the public, thus improving the quality of the advertisements. Companies recognize the benefits this advisory review mechanism offers. In fact, PhRMA recently stated in its voluntary guidance principles on DTC advertising that companies should submit all new DTC television advertisements to FDA before broadcasting them *http://www.phrma.org/files/DTCGuidingprinciples.pdf* . However, although FDA's DTC advisory review workload has been steadily increasing, staffing for this activity has remained level. As a result, it is impossible for FDA to review all of the DTC television advertisement advisory submissions it receives in a timely manner. The lack of timely, predictable FDA review times for DTC television advertisements is detrimental to companies' ability to accurately set timeframes for their marketing campaigns and discourages companies from submitting these materials for advisory review. We propose creating a separate program, not directly included under PDUFA IV, to assess, collect, and use fees for the advisory review of prescription drug television advertisements. These user fees would not be funded by application, product, or establishment fees assessed under PDUFA. Instead, these new fees would be assessed separately and collected only from those companies that intend to seek FDA advisory reviews of DTC television advertisements. The proposed recommendation for fee funding and the estimated number of supported staff are summarized in table 2 of this document. **Table 2.—Proposed Fees for DTC Advertisement Review (starting in FY 2008)** Proposed Program Dollars FTE Advisory Review of DTC Television Advertisements $6,250,000 27 Program Total (in FY 2008) $6,250,000 27 This program would provide for increased FDA resources to allow for the timely review of DTC television advertisement advisory submissions. To ensure stable funding for the program in case the number of advisory submissions fluctuates widely from year to year, the program would assess a one-time participation fee. The program would then charge fees each year for each advisory review requested. These new fees would provide sufficient resources for FDA to hire additional staff to review DTC television advisory submissions in a predictable, timely manner. FDA anticipates collecting $6.25 million in annual fees during the first year of the program (and a similar amount to go into the reserve fund) to support 27 additional staff to review DTC television advertising. Advisory review fee amounts would be adjusted annually for inflation and to take into account increases in workload. As part of this program, FDA is proposing to commit to certain performance goals including review of a certain number of original advisory review submissions in 45 days and resubmissions in 30 days. The goals would be phased in over the 5 years of the program to allow for recruitment and training of staff. IV. What Information Should You Know About the Meeting? A. When and Where Will the Meeting Occur? What Format Will We Use? Through this document, we are announcing the convening of a public meeting to hear stakeholder views on the recommendations we propose to provide to Congress on the reauthorization of PDUFA IV. We will conduct the meeting on February 16, 2007, at the Grand Hyatt Washington at Washington Center (see ADDRESSES ). In general, the meeting format will include presentations by FDA and a series of panels representing different stakeholder interest groups (such as patient advocates, consumer advocates, industry, health professionals, and academic researchers). We will also give individuals the opportunity to make presentations at the meeting, and for organizations and individuals to submit written comments to the docket after the meeting. B. How Do You Register for the Meeting or Submit Comments? If you wish to attend and/or make a presentation at the meeting, please send an electronic mail message to *CBERTrainingSuggestions@fda.hhs.gov* by February 2, 2007. Your e-mail should include the following information: Name, Company, Company Address, Company Phone Number, and E-mail Address. You will receive a confirmation within 2 business days. We also will accept walk-in registration at the meeting site, but space is limited, and we will close registration when maximum seating capacity (approximately 500) is reached. We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak Additionally, regardless of whether you wish to make a presentation or simply attend the meeting, please notify us if you need any special accommodations (such as wheelchair access or a sign language interpreter). If you would like to submit comments regarding these proposed recommendations, please send your comments to the Division of Dockets Management (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any written comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. To ensure consideration of your comments, you should send your comments no later than February 23, 2007. C. Will Meeting Transcripts Be Available? We will prepare a meeting transcript and make it available on our Web site ( *www.fda.gov* ) after the meeting. We anticipate that transcripts will be available approximately 30 business days after the meeting. The transcript will also be available for public examination at the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m. Monday through Friday. Dated: January 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-122 Filed 1-11-07; 8:45 am]

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