Notices. Notice

8,282 words·~38 min read·/register/2007/08/16/07-4016

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4151-05-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07BL] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-4766 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(PFDs)and Commercial Fishermen: Preconceptions and Evaluation in Actual Use—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description NIOSH has the responsibility under Pub. L. 91-596 section 20 (Occupational Safety and Health Act of 1970) to conduct research relating to innovative methods, techniques, and approaches for dealing with occupational safety and health problems. Commercial fishing is one of the most dangerous occupations in the United States, with a fatality rate 30 times higher than the national average. Most fishermen who die on the job drown subsequent to a vessel sinking (51%) or fall overboard (29%). Because drowning is the leading cause of death for commercial fishermen, its prevention is one of the highest priorities for those who work to make the industry safer. The risk of drowning for commercial fisherman is high, yet most fishermen do not wear Personal Flotation Devices

(PFDs)while on deck. From 1990 to 2005, 71 commercial fishermen drowned subsequent to a fall overboard in Alaska. None of the victims were wearing a PFD, and many were within minutes of being rescued when they lost their strength and disappeared under the surface of the water. Although there are many new styles of PFDs on the market, it is unknown how many commercial fishermen are aware of them, or if they are more comfortable and wearable than the older styles. There have not been any published studies testing PFDs on commercial fisherman to measure product attributes and satisfaction. The purpose of this study is to first, identify fishermen's perceptions of risk, safety attitudes, and beliefs about PFDs; and second, to evaluate a variety of modern PFDs with commercial fishermen to discover the features and qualities that they like and dislike. This study addresses the repeated recommendation by NIOSH that all commercial fishermen wear PFDs while on deck. Study Design NIOSH is requesting OMB approval to administer a survey to fishermen operating in several fisheries in Southwest Alaska. This questionnaire will contain questions that measure fishermen's risk perceptions, safety attitudes, and beliefs about PFDs. The questionnaire is short and will take about 20 minutes to complete. The sample size was determined to be 370 respondents in order to achieve a 95% confidence level. Additionally, NIOSH is requesting approval to involve fishermen directly with an evaluation of the wearability of several different styles of PFDs during fishing operations. Fishermen will be asked to wear one of several styles of PFDs during their fishing season and rate the comfort and features that the PFD has. The PFD ratings will be collected at three times during the evaluation period, using a short form. Each of the three evaluation forms will take about 10 minutes to complete. The sample size for this portion of the study is 145 respondents but will still have a 95% confidence level. The purpose of this portion is to inform potential purchasers of PFD's of other fishermen's evaluations of different styles based on their experience with their use. This study has the potential to greatly benefit the fishing industry. One of the first steps to increasing PFD use among commercial fishermen is gaining an understanding of fishermen's reasons for not wearing PFDs. With the empirical data at hand, safety professionals may be better equipped to address fishermen's concerns and remove the barriers that are currently in place. Findings from the PFD evaluations will provide manufacturers valuable information about commercial fishermen's needs and expectations of PFDs. Because the PFD wearability ratings will be completed by fishermen during fishing operations, the results may have more credibility when they are disseminated to the industry. The PFD evaluation will also supply information to fishermen about which types of PFDs worked best for different types of fishing operations. There are no costs to respondents other than their time. Estimated Annualized Burden Hours Type of Respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Fishermen (Survey) 370 1 20/60 123 Fishermen (Evaluation) 145 3 10/60 73 Total 196 Dated: August 10, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-16113 Filed 8-15-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0210] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-371-5960 or send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products (OMB No. 0920-0210)—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Comprehensive Smoking Education Act of 1984 (15 U.S.C. 1336 or Pub. L. 98-474) requires each person who manufactures, packages, or imports cigarettes to provide the Secretary of Health and Human Services

(HHS)with a list of ingredients added to tobacco in the manufacture of cigarettes. This legislation also authorizes HHS to undertake research, and to report to the Congress (as deemed appropriate) discussing the health effects of these ingredients. HHS has delegated responsibility for the implementation of this Act to CDC's Office on Smoking and Health (OSH). OSH has collected ingredient reports on cigarette products since 1986. Cigarette smoking is the leading preventable cause of premature death and disability in our Nation. Each year more than 400,000 premature deaths occur as the result of cigarette smoking related diseases. The Centers for Disease Control and Prevention (CDC), Office on Smoking and Health

(OSH)has been delegated the authority for implementing major components of the Department of Health and Human Services'

(HHS)tobacco and health program, including collection of tobacco ingredients information. HHS's overall goal is to reduce death and disability resulting from cigarette smoking and other forms of tobacco use through programs of information, education and research. For the 2006 reporting year, 111 cigarette manufacturers and/or importers submitted ingredient reports to CDC. The total annual response burden reported for all 111 companies was 722 hours at a total cost of $34,315. The average annual response burden for each company was 6.5 hours at a cost of $47.56 per company. The cost to respondents is their time to complete the survey. The 111 manufacturers and/or importers were used as the respondent population for this submission. Estimated Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response (in hours) Total burden (in hours) Cigarette Manfacturers 111 1 6.5 722 Dated: August 10, 2007. Maryam Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-16119 Filed 8-15-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0679] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(MIS)for the Division for Heart Disease and Stroke Prevention—REVSION—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In 1993, the U.S. Congress authorized the Centers for Disease Control and Prevention

(CDC)to establish the WISEWOMAN demonstration program to extend the services provided within the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) framework. A subset of the women (those who are 40-64 years of age) who participate in NBCCEDP may also participate in WISEWOMAN. Addressing risk factors such as elevated cholesterol, high blood pressure, obesity, sedentary lifestyle, poor diet, diabetes, and smoking can help reduce a woman's risk of cardiovascular disease-related illness and death. The Division for Heart Disease and Stroke Division Management Information System will collect in electronic format:

(a)Data needed to measure progress by State Heart Disease and Stroke Prevention and WISEWOMAN Programs toward, or achievement of, program performance measures. The respondent population will consist of State Health Department Heart Disease and Stroke Prevention Program Managers and WISEWOMEN Program Managers. There are no costs to respondents except their time to participate in the survey. Thirty-four respondents from HDSP program and 15 respondents from the WISEWOMAN program will provide input into the proposed system. Respondents reside in each of 39 States, two Tribal organizations, and the District of Columbia. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) State Health Officials 49 2 6 588 Dated: August 10, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-16120 Filed 8-15-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-308, CMS-116, CMS-1561/1561A, CMS-417, CMS-10227, CMS-437, CMS-724, CMS-10116, CMS-10142, and CMS-10225] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* State Children's Health Insurance Program and Supporting Regulations in 42 CFR 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, and 457.1180; *Form Number:* CMS-R-308 (OMB#: 0938-0841) *Use:* States are required to submit title XXI plans and amendments for approval by the Secretary pursuant to section 2102 of the Social Security Act in order to receive funds for initiating and expanding health insurance coverage for uninsured children. States are also required to submit State expenditure and statistical reports, annual reports and State evaluations to the Secretary as outlined in title XXI of the Social Security Act. *Frequency:* Yearly and Quarterly; *Affected Public:* State, Local or Tribal governments; *Number of Respondents:* 56; *Total Annual Responses:* 1,454,601; *Total Annual Hours:* 864,933. 2. *Type of Information Collection Request:* Revision of a currently approved collection. In this revision, a number of changes were made to the form and accompanying instructions to facilitate the completion and data entry of the form. Specifically, the enumeration of individuals involved in laboratory testing was eliminated, and the reporting of hours of laboratory operations was streamlined. Some fields were expanded to reflect changes in laboratory demographics (added prison and assisted living facility to location of laboratory testing) and to collect complete information on the number of tests performed in laboratories. There are no program changes; *Title of Information Collection:* Clinical Laboratory Improvement Amendments Application Form and Supporting Regulations at 42 CFR 493.1-.2001; *Form Number:* CMS-116 (OMB#: 0938-0581); *Use:* The application must be completed by entities performing laboratory testing specimens for diagnostic or treatment purposes. This information is vital to the certification process. *Frequency:* Reporting—Biennially; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 187,000; *Total Annual Responses:* 17,960; *Total Annual Hours:* 22,450. 3. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR 489; *Form Numbers:* CMS-1561 and 1561A (OMB#: 0938-0832); *Use:* Applicants to the Medicare program are required to agree to provide services in accordance with Federal requirements. The CMS-1561 and 1561A are essential for CMS to ensure that applicants are in compliance with the requirements. Applicants will be required to sign the completed form and provide operational information to CMS to assure that they continue to meet the requirements after approval; *Frequency:* Reporting—Other: All new applicants must complete; *Affected Public:* State, Local or Tribal Governments, Business or Other for-profits and Not-for-profit institutions; *Number of Respondents:* 3,300; *Total Annual Responses:* 3,300; *Total Annual Hours:* 275. 4. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Hospice Request for Certification in the Medicare Program; *Form Number:* CMS-417 (OMB#: 0938-0313); *Use:* The Hospice Request for Certification Form is the identification and screening form used to initiate the certification process and to determine if the provider has sufficient personnel to participate in the Medicare program; *Frequency:* Reporting—Yearly; *Affected Public:* Private Sector: Business or other for-profits; *Number of Respondents:* 2,286; *Total Annual Responses:* 2,286; Total Annual Hours: 572. 5. *Type of Information Collection Request:* Existing collection in use without an OMB Control Number; *Title of Information Collection:* PACE State Plan Amendment Pre-print; *Form Number:* CMS-10227 (OMB#: 0938-NEW); *Use:* The Balanced Budget Act of 1997 created section 1934 of the Social Security Act that established the Program for the All-Inclusive Care for the Elderly (PACE). The legislation established the PACE program as a Medicaid State plan option serving the frail and elderly in the home and community. In accordance with the rule published in the November 24, 1999 **Federal Register** (64 FR 66271), if a State elects to offer PACE as an optional Medicaid benefit, it must complete a State Plan Amendment described as Enclosures #3, 4, 5, 6 and 7. In State Medicaid Director letters dated March 23, 1998 and November 9, 2000, CMS advised States that it had provided a suggested pre-print and supplemental pages for a State to express its intention to elect PACE as an option to its State plans. As pre-print packet Enclosures #3-7 were suggested and not required, CMS did not believe at the time that a suggested form required clearance from OMB. The PACE regulation 42 CFR Part 460 was first published in the **Federal Register** as an interim final rule on November 24, 1999. The final PACE rule was published on December 8, 2006. CMS is seeking OMB approval to use Enclosures #3, 4, 5, 6 and 7. The information is used by CMS to affirm that the State elects to offer PACE an optional State plan service and the specifications of eligibility, payment and enrollment for the program. *Frequency:* Reporting—Once; *Affected Public:* State, Local or Tribal Governments; *Number of Respondents:* 56; *Total Annual Responses:* 56 possible responses but we have only received 20 thus far; *Total Annual Hours:* 1,120. 6. *Type of Information Collection Request:* Reinstatement with change of a previously approved collection; *Title of Information Collection:* Psychiatric Unit Criteria Worksheet and Supporting Regulations at 42 CFR 412.25 and 412.27. *Form Number:* CMS-437 (OMB# 0938-0358); *Use:* The psychiatric unit criteria worksheets are necessary to verify that these units comply and remain in compliance with the exclusion criteria for the Medicare prospective payment system. *Frequency:* Reporting—Annually; *Affected Public:* Business or other for-profit, Not-for-profit institutions, and State, Local and Tribal Government; *Number of Respondents:* 1,333; *Total Annual Responses:* 1,333; *Total Annual Hours:* 333. 7. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Psychiatric Hospital Survey Data and Supporting Regulations at 42 CFR 482.60, 482.61, and 482.62; *Form Number:* CMS-724 (OMB#: 0938-0378); *Use:* The Medicare/Medicaid Psychiatric Hospital Survey is used to collect data that is not collected elsewhere and assists CMS in program planning and evaluation of survey needs. In addition, the survey assists CMS in maintaining an accurate data base on providers participating in the Medicare psychiatric hospital program; *Frequency:* Reporting—Yearly; *Affected Public:* Private Sector: Business or other for-profits; *Number of Respondents:* 420; *Total Annual Responses:* 200; *Total Annual Hours:* 100. 8. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Program; Conditions of Payment of Power Mobility Devices, Including Power Wheelchairs and Power-Operated Vehicles (CMS-3017-F); *Form Numbers:* CMS-10116 (OMB#: 0938-0971); *Use:* The CMS is seeking the reapproval of the collection requirements associated with the final rule, CMS-3017-F (71 FR 17021), which was published on April 5, 2006, and became effective on June 5, 2006. Specifically, we are seeking OMB approval for the following terms of clearance identified in the Notice of Action dated October 16, 2006, of which OMB has requested CMS to monitor the paperwork burden required of providers and suppliers to determine if the paperwork requirements impose any unnecessary burden on the industry and/or need to be revised in order to improve the utility of the information. After analyzing the documentation requirements burden, CMS does not believe that the documentation requirements impose any additional unnecessary burden on the durable medical equipment

(DME)Industry. We believe that most physicians are already conducting a face-to-face examination before prescribing a wheelchair. Given that physicians and treating practitioners can now prescribe power-operated vehicles (POVs), thereby removing the requirement that a specialist can order a POV, CMS believes that the increased burden of 48,600 hours for physicians and treating practitioners is based on the Congressional decision to allow a broader range of physicians and treating practitioners to prescribe POVs. This increased burden is offset by the new payments implemented in connection with the Final Rule, which is demonstrated by the shift in prescriptions from one class of equipment, power wheelchairs, to another class of equipment, POVs. In addition, CMS believes that with the recent coverage decision on Mobility Assistive Equipment, the implementing details in the Final Rule (e.g., improved documentation for suppliers; physician and treating practitioner payments; improved classification of mobility equipment; the elimination of the certificate of medical necessity (CMN)), and the provider outreach and education provided by CMS, the DME program safeguard contractors

(PSCs)and DME Medicare administrative contractors (MACs), the needs of mobility-impaired beneficiaries and the needs of suppliers have been better met. *Frequency:* Recordkeeping—On occasion; *Affected Public:* Business or for-profits, Not-for-profit institutions, and State, Local or Tribal governments; *Number of Respondents:* 38,000; * Total Annual Responses:* 243,000; *Total Annual Hours:* 48,600. 9. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Bid Pricing Tool

(BPT)for Medicare Advantage

(MA)Plans and Prescription Drug Plans (PDPs); *Use:* Under the Medicare Prescription Drug, Improvement, and Modernization (MMA), Medicare Advantage organizations

(MAO)and Prescription Drug Plans

(PDP)are required to submit an actuarial pricing “bid” for each plan offered to Medicare beneficiaries. CMS requires that MAOs and PDPs complete the BPT as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to CMS for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan's bid, enrollee premiums, and payment rates. *Form Number:* CMS-10142 (OMB#: 0938-0944); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 550 *Total Annual Responses:* 6,050; *Total Annual Hours:* 42,350. 10. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Disclosures to Patients by Certain Hospitals and Critical Access Hospitals; Form Numbers: CMS-10225 (OMB#: 0938-New); *Use:* There is no Medicare prohibition against physician investment in a hospital or critical access hospital (CAH). Likewise, there is no Medicare requirement that a hospital or CAH have a physician on-site at all times, although there is a requirement that they be able to provide basic elements of emergency care to their patients. Medicare quality and safety standards are designed to provide a national framework that is sufficiently flexible to apply simultaneously to hospitals of varying sizes, offering varying ranges of services in differing settings across the Nation. At the same time, however, patients might consider an ownership interest by their referring physician and/or the presence of a physician on-site to be important factors in their decisions about where to seek hospital care. A well-educated consumer is essential to improving the quality and efficiency of the healthcare system. Accordingly, patients should be made aware of the physician ownership of a hospital, whether or not a physician is present in the hospital at all times, and the hospital's plans to address patients' emergency medical conditions when a physician is not present. The intent of the proposed disclosures are increase the transparency of the hospital's ownership and operations to patients as they make decisions about receiving care at the hospital. Based on public comments received during the 60-day comment period for the **Federal Register** notice (72 FR 21024) for this information collection request, we revised our burden estimates to include the burden associated with the physician-ownership disclosure and recordkeeping requirement for outpatient visits. In addition, we revised the burden associated with the disclosure requirement for critical access hospitals that may not have a physician on-site at all times to account for outpatient visits as well. *Frequency:* Reporting—On occasion; *Affected Public:* Business or for-profits, Not-for-profit institutions; *Number of Respondents:* 2,679; *Total Annual Responses:* 52,984,510; *Total Annual Hours:* 839,599. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: August 9, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-16160 Filed 8-15-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0306] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for current good manufacturing practice

(cGMP)regulations for Type A medicated articles. DATES: Submit written or electronic comments on the collection of information by October 15, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Current Good Manufacturing Practice Regulations for Type A Medicated Articles—21 CFR Part 226 (OMB Control Number 0910-0154)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351), FDA has the statutory authority to issue cGMP regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Statutory requirements for cGMPs for Type A medicated articles have been codified under part 226 (21 CFR part 226). Type A medicated articles which are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the act. Under part 226, a manufacturer is required to establish, maintain, and retain records for type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e., batch and stability testing) and product distribution. This information is needed so that FDA can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to FDA in investigating product defects when a drug is recalled. In addition, FDA will use the cGMP criteria under part 226 to determine whether or not the systems used by manufacturers of Type A medicated articles are adequate to assure that their medicated articles meet the requirements of the act as to safety and also meet the article's claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the act. The respondents for Type A medicated articles are pharmaceutical firms that manufacture both human and veterinary drugs, those firms that produce only veterinary drugs, and commercial feed mills. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total 226.42 115 260 29,000 0.75 22,425 226.58 115 260 29,000 1.75 52,325 226.80 115 260 29,000 0.75 22,425 226.102 115 260 24,000 1.75 52,325 226.110 115 260 29,000 0.25 7,475 226.115 115 10 1,150 0.5 575 Total 157,550 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the time required for record preparation and maintenance is based on agency communications with industry. Other information needed to calculate the total burden hours (i.e., manufacturing sites, number of Type A medicated articles being manufactured, etc.) are derived from agency records and experience. Dated: August 9, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-16087 Filed 8-15-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0305] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for current good manufacturing practice

(cGMP)regulations for medicated feeds. DATES: Submit written or electronic comments on the collection of information by October 15, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351), FDA has the statutory authority to issue cGMP regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution. This information is needed so that FDA can monitor drug usage and possible misformulation of medicated feeds, to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria under part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the act as to safety and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the act. A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. Respondents to this collection of information are commercial feed mills and mixer-feeders. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours per Recordkeeper Total Hours 225.58(c) and

(d)1,060 45 47,700 .5 23,850 225.80(b)(2) 1,060 1,600 1,696,000 .12 203,520 225.102(b)(1) 1,060 7,800 8,268,000 .08 661,440 225.110(b)(1) and (b)(2) 1,060 7,800 8,268,000 .015 124,020 225.115(b)(1) and (b)(2) 1,060 5 5,300 .12 636 Total 1,289,066 1 There are no capital or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.42(b)(5) through (b)(8) 100 260 26,000 .15 3,900 225.58(c) and

(d)100 36 3,600 .5 1,800 225.80(b)(2) 100 48 4,800 .12 576 225.102(b)(1) through (b)(5) 100 260 26,000 .4 10,400 Total 16,676 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 3.—Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Commercial Feed Mills)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.142 8,000 4 32,000 1 32,000 225.158 8,000 1 8,000 4 32,000 225.180 8,000 96 768,000 .12 92,160 225.202 8,000 260 2,080,000 .65 1,352,000 Total 1,508,160 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 4.—Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.142 45,000 4 180,000 1 180,000 225.158 45,000 1 45,000 4 180,000 225.180 45,000 32 1,440,000 .12 172,000 225.202 45,000 260 11,700,000 .33 3,861,000 Total 4,393,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from agency records and experience. Dated: August 9, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-16088 Filed 8-15-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P-0074] Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committees* : Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. *General Function of the Committees* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on October 18 and 19, 2007, from 8 a.m. to 5 p.m. *Addresses* : Electronic comments should be submitted to *http://www.fda.gov/dockets/ecomments* . Select “2007P-0074—Final Monongraph for Cough, Cold, Allergy, Brochodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, by close of business on August 28, 2007. *Location* : The National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring, MD. The phone number is 301-431-6400. *Contact Person* : Darrell Lyons, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *darrell.lyons@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 3014512541 and 8732310001. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The committees will meet in joint session to discuss the safety and efficacy of over-the-counter

(OTC)cough and cold products marketed for pediatric use. A citizen petition was submitted to FDA on March 1, 2007, that raised concerns about the safety and efficacy of cough and cold products in children under 6 years of age. The petition requested among other things that FDA amend the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (CCABADP) in 21 CFR Part 341 to require that labeling for OTC antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state that these products have not been found to be safe or effective in children under 6 years of age for the treatment of cough and cold, and that these products should not be used for the treatment of cough and cold in children under 6 years of age. In addition, the petitioner requested the agency to notify manufacturers of these products whose labeling either uses such terms as “infant” or “baby” or displays images of children under the age of 6, that such marketing is not supported by scientific evidence and that manufacturers will be subject to enforcement action at any time. The petition and additional information can be found at the following Web site: *http://www.fda.gov/ohrms/dockets/dockets/07p0074/07p0074.htm* . The committee's discussion will focus on several areas of interest which include: The extrapolation of efficacy data from adults to children of any age for cough and cold products; the safety profile of these products in children; the basis for dosing recommendations in the CCABADP monograph and the use of extrapolation of pharmacokinetic data to determine appropriate dosing in children; the basis of dosing recommendations for various age intervals of less than 2 years, 2 to 5 years of age, and 6 to 11 years of age; the use of the products in children less than 2 years of age; the potential for misuse, unintentional overdose, and excessive dosing; the ability of parents or caregivers to correctly dose and administer cough and cold products to their children; and the potential labeling changes recommended by the petitioner and the effects they will have on the use of these products in children and the recommendations of health providers. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* ; click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 3, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 3 p.m. on October 18, 2007. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 26, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Darrell Lyons at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 9, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-16169 Filed 8-15-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Processing Methods for Orthopedic, Cardiovascular, and Skin Allografts; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Office of Regulatory Affairs

(ORA)and the Centers for Disease Control and Prevention

(CDC)are announcing a public workshop entitled “Processing Methods for Orthopedic, Cardiovascular, and Skin Allografts.” The purpose of the public workshop is to discuss various methods used to process tissue allograft, pre- and post-processing cultures, and disinfection and sterilization of tissues. *Date and Time* : The public workshop will be held on October 11, 2007, from 8:30 a.m. to 5 p.m., and October 12, 2007, from 8:30 a.m. to 1 p.m. *Location* : The public workshop will be held at the Masur Auditorium, Building 10 Clinical Center, National Institutes of Health, Bethesda, MD 20892. *Contact* : Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, e-mail: *CBERTrainingSuggestions@fda.hhs.gov* (Subject line: Tissue Processing Workshop). *Registration* : Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by September 18, 2007. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m. If you need special accommodations due to a disability, please contact Bernadette Kawaley (see *Contact* ) at least 7 days in advance. SUPPLEMENTARY INFORMATION: The public workshop will feature presentations by experts from the government, the medical field and the tissue industry. The first day of the workshop will include discussions on:

(1)Surgeon clinical practices, experiences, expectations, and assumptions regarding tissue allografts and patient safety; and

(2)Pre- and Post-Processing cultures for microorganisms—usefulness, reliability, and validation. The second day of the workshop will focus on disinfection and sterilization of tissues—experiences, expectations, and challenges. *Transcripts* : Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at *http://www.fda.gov/cber/minutes/workshop-min.htm* . Dated: August 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-16182 Filed 8-15-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.c. Appendix 2), notice is hereby given of a meeting of the National Cancer Institute Director's Consumer Liaison Group. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* National Cancer Institute Director's Consumer Liaison Group. *Date:* October 24-25, 2007. *Time:* 8:30 a.m. to 3:30 p.m. *Agenda:* 1. Approval of Minutes; 2. Reports from Dr. John E. Niederhuber, NCI Director; 3. Reports on NCI Budget; Legislative Activity; NCI Scientific Initiatives reported by NCI staff; 4. Presentations on Eliminating Cancer Health Disparities; Translational Working Group; and the Adolescent and Young Adult Oncology

(AYAO)Progress Review Group

(PRG)5. Public Comment; 6. Action Items and Conclusion. *Place:* National Institutes of Health, Building 31, 9000 Rockville Pike, C Wing, 6th Floor, Conference Rm. 6, Bethesda, MD 20892. *Contact Person:* Barbara Guest, Executive Secretary, Office of Liaison Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Blvd, Room 2202, Bethesda, MD 20892-8324, Bethesda, MD 20892-8324, 301-496-0307, *guestb@mail.nih.gov.* Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show on form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's home page: *deainfo.nci.nih.gov/advisory/dclg/dclg.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of health, HHS) Dated: August 9, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-4016 Filed 8-15-07; 8:45 am]

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