Notices. Notice of hearing

7,442 words·~34 min read·/register/2006/01/24/06-652

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

BILLING CODE 4163-19-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval of Ohio State Plan Amendments 05-07 and 05-020 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of hearing. SUMMARY: This notice announces an administrative hearing to be held on February 28, 2006, in Suite #500, 233 N. Michigan Avenue, Minnesota Conference Room, Chicago, IL 60202, to reconsider CMS' decision to disapprove Ohio State plan amendments 05-07 and 05-020. *Closing Date:* Requests to participate in the hearing as a party must be received by the presiding officer by February 8, 2006.

FOR FURTHER INFORMATION CONTACT: Kathleen Scully-Hayes, Presiding Officer, CMS, Lord Baltimore Drive, Mail Stop LB-23-20, Baltimore, Maryland 21244. Telephone:

(410)786-2055. SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS' decision to disapprove Ohio State plan amendments

(SPAs)05-07 and 05-020, which were submitted on August 1, 2005, and September 1, 2005, respectively. Both SPAs were disapproved on October 28, 2005. Under SPAs 05-07 and 05-020, Ohio sought to implement the Medicaid School Program. The amendments were disapproved because they do not comport with the requirements of section 1902(a) of the Social Security Act (the Act) and implementing regulations. The specific reasons for disapproval are identified below. Under section 1902(a)(10) of the Act, a State plan must provide for making medical assistance available to eligible individuals. “Medical assistance,” as defined in section 1905(a) of the Act, does not include habilitation services. After CMS determined that habilitation services were not properly included within the scope of the statutory category of rehabilitation services, the Omnibus Budget Reconciliation Act of 1989 (OBRA-89) “grandfathered” certain States, including Ohio, to provide habilitation services under previously approved State plan provisions as part of the Medicaid rehabilitation benefit. However, Ohio formally terminated its habilitation services (known as the “Community Alternative Funding System,” or CAFS program) in SPA 05-008 and, thus, is no longer “grandfathered” based on its previously approved State plan provision. Because there is no provision of the State's Medicaid plan as approved on or before June 30, 1989, that provides coverage of habilitation services in the State's current approved plan, the provisions of section 6411(g)(1)(A) of OBRA-89, that prohibit the Secretary from withholding, suspending, disallowing, or denying Federal financial participation for habilitation services, no longer apply. In addition, the SPAs do not comply with the requirements of section 1902(a)(1) of the Act that services under the plan be available statewide. Under the SPAs, services would be covered only for select groups of students in participating schools but services would not be available to other eligible individuals. Because not all parts of the State may have participating schools, the SPAs violate statewideness requirements. The restricted availability of services also violates the requirements of section 1902(a)(10)(B) of the Act that services available to each individual within a Medicaid eligibility group must be comparable in amount, duration, and scope (and that services available to categorically needy groups cannot be less in amount, duration, and scope than those available to the medically needy). The SPAs are not consistent with comparability requirements because the services are available only to select groups of students. Additionally, these SPAs explicitly deny the provision of Medicaid fair hearing requests for individuals who are denied services. This provision is at variance with section 1902(a)(3) of the Act and Federal regulations at 42 CFR 431.200(a) which require that a State plan “provide an opportunity for a fair hearing to any person whose claim for assistance is denied or not acted upon promptly.” In addition, the State did not demonstrate that the proposed payment methodology would comply with the statutory requirements of sections 1902(a)(2), 1902(a)(30)(A), and 1903(a)(1) of the Act, which require that the State plan assure adequate funding for the non-Federal share of expenditures from State or local sources; that State or local sources have methods and procedures to assure that payments are consistent with efficiency, economy, and quality of care; and that Federal matching funds are only available for actual expenditures made by States for services under the approved plan. The State did not respond fully to CMS' requests for information concerning State payment and funding issues. Absent such information, CMS could not determine whether the proposed SPA would operate in compliance with all applicable requirements of section 1902(a) of the Act. Finally, for Ohio SPA 05-020 alone, the State did not show compliance with section 1902(a)(4) of the Act, which specifies that the State plan must provide for such methods of administration as are found by the Secretary to be necessary for the proper and efficient administration of the plan. Pursuant to this provision, States must include in their State plans all information necessary for CMS to determine whether the plan can be approved to serve as a basis for Federal financial participation. Absent information on the methodology used to develop the fee schedules, this requirement is not met. For the reasons cited above, and after consultation with the Secretary, as required by 42 CFR 430.15(c)(2), Ohio SPAs 05-07 and 05-020 were disapproved. Section 1116 of the Act and Federal regulations at 42 CFR Part 430, establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. CMS is required to publish a copy of the notice to a State Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as *amicus curiae* must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants. The notice to Ohio announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows: Mr. Jim Petro, Office of the Attorney General, Health & Human Services Section, 30 E. Broad Street, 26th Floor, Columbus, OH 43215-3400. Dear Mr. Petro: I am responding to your request for reconsideration of the decision to disapprove Ohio State plan amendments

(SPAs)05-07 and 05-020, which were submitted on August 1, 2005, and September 1, 2005, respectively, and disapproved on October 28, 2005. Under SPAs 05-07 and 05-020, Ohio was seeking to implement the Medicaid School Program. The amendments were disapproved because they did not comport with the requirements of section 1902(a) of the Social Security Act (the Act) and implementing regulations. The specific reasons for disapproval are identified below. Under section 1902(a)(10) of the Act, a State plan must provide for making medical assistance available to eligible individuals. “Medical assistance,” as defined in section 1905(a) of the Act, does not include habilitation services. After the Centers for Medicare & Medicaid Services

(CMS)determined that habilitation services were not properly included within the scope of the statutory category of rehabilitation services, the Omnibus Budget Reconciliation Act of 1989 (OBRA-89) “grandfathered” certain States, including Ohio, to provide habilitation services under previously approved State plan provisions as part of the Medicaid rehabilitation benefit. However, Ohio formally terminated its habilitation services (known as the “Community Alternative Funding System,” or CAFS program) in SPA 05-008 and, thus, is no longer “grandfathered” based on its previously approved State plan provision. Because there is no provision of the State's Medicaid plan as approved on or before June 30, 1989, that provides coverage of habilitation services in the State's current approved plan, the provisions of section 6411(g)(1)(A) of OBRA-89, that prohibit the Secretary from withholding, suspending, disallowing, or denying Federal financial participation for habilitation services, no longer apply. In addition, the SPAs do not comply with the requirements of section 1902(a)(1) of the Act that services under the plan be available statewide. Under the SPAs, services would be covered only for select groups of students in participating schools but services would not be available to other eligible individuals. Because not all parts of the State may have participating schools, the SPAs violate statewideness requirements. The restricted availability of services also violates the requirements of section 1902(a)(10)(B) of the Act that services available to each individual within a Medicaid eligibility group must be comparable in amount, duration, and scope (and that services available to categorically needy groups cannot be less in amount, duration, and scope than those available to the medically needy). The SPAs are not consistent with comparability requirements because the services are available only to select groups of students. Additionally, these SPAs explicitly deny the provision of Medicaid fair hearing requests for individuals who are denied services. This provision is at variance with section 1902(a)(3) of the Act and Federal regulations at 42 CFR 431.200(a) which require that a State plan “provide an opportunity for a fair hearing to any person whose claim for assistance is denied or not acted upon promptly.” In addition, the State did not demonstrate that the proposed payment methodology would comply with the statutory requirements of sections 1902(a)(2), 1902(a)(30)(A), and 1903(a)(1) of the Act, which require that the State plan assure adequate funding for the non-Federal share of expenditures from State or local sources; that State or local sources have methods and procedures to assure that payments are consistent with efficiency, economy, and quality of care; and that Federal matching funds are only available for actual expenditures made by States for services under the approved plan. The State did not respond fully to CMS' requests for information concerning State payment and funding issues. Absent such information, CMS could not determine whether the proposed SPA would operate in compliance with all applicable requirements of section 1902(a) of the Act. Finally, for Ohio SPA 05-020 alone, the State did not show compliance with section 1902(a)(4) of the Act, which specifies that the State plan must provide for such methods of administration as are found by the Secretary to be necessary for the proper and efficient administration of the plan. Pursuant to this provision, States must include in their State plans all information necessary for CMS to determine whether the plan can be approved to serve as a basis for Federal financial participation. Absent information on the methodology used to develop the fee schedules, this requirement is not met. For the reasons cited above, and after consultation with the Secretary, as required by 42 CFR 430.15(c)(2), Ohio SPAs 05-07 and 05-020 were disapproved. I am scheduling a hearing on your request for reconsideration to be held on February 28, 2006, at Suite #500, 233 N. Michigan Avenue, Minnesota Conference Room, Chicago, IL 60202, to reconsider the decision to disapprove SPA 05-07 and 05-020. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed at 42 CFR Part 430. I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer at

(410)786-2055. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. Sincerely, Mark B. McClellan, MD., PhD. Section 1116 of the Social Security Act (42 U.S.C. 1316); 42 CFR 430.18. (Catalog of Federal Domestic Assistance Program No. 13.714, Medicaid Assistance Program) Dated: January 13, 2006. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E6-788 Filed 1-23-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0396] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(CDER)and the Center for Biologics Evaluation and Research

(CBER)that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The guidance provides information on how the agency will interpret and apply provisions of the existing regulations regarding internal agency review of decisions (§ 10.75 (21 CFR 10.75)) and dispute resolution during the investigational new drug

(IND)process (21 CFR 312.48) and the new drug application/abbreviated new drug application (NDA/ANDA) process (21 CFR 314.103). In addition, the guidance provides information on how the agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products. Existing regulations, which appear primarily in parts 10, 312, and 314 (21 CFR parts 10, 312, and 314), establish procedures for the resolution of scientific and procedural disputes between interested persons and the agency, CDER, and CBER. All agency decisions on such matters are based on information in the administrative file (§ 10.75(d)). In general, the information in an administrative file is collected under existing regulations in parts 312 (OMB Control No. 0910-0014), 314 (OMB Control No. 0910-0001), and part 601 (21 CFR part 601) (OMB Control No. 0910-0338), which specify the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. While FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the dispute. The guidance describes the following collection of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution. Agency regulations (§§ 312.23(d), 314.50, 314.94, and 601.2) state that information provided to the agency as part of an IND, NDA, ANDA, or BLA is to be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571, OMB Control No. 0910-0014, expires January 31, 2006; and FDA Form 356h, OMB Control No. 0910-0338, expires August 31, 2005. In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The agency recommends that a request be submitted as an amendment in this manner for two reasons: To ensure that each request is kept in the administrative file with the entire underlying application and to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the appropriate agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner. CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the center may quickly and efficiently respond to the request:

(1)A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome;

(2)a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last agency official that attempted to formally resolve the matter;

(3)a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and

(4)a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the agency suggests submitting with a formal request for dispute resolution consists of:

(1)Statements describing the issue from the perspective of the person with a dispute,

(2)brief statements describing the history of the matter, and

(3)the documents previously submitted to FDA under an OMB approved collection of information. Based on FDA's experience with dispute resolution, the agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal. *Description of Respondents* : A sponsor, applicant, or manufacturer of a drug or biological product regulated by the agency under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute. *Burden Estimate* : Provided in table 1 of this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 8 sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately 1 respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 10 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 88 hours will be spent per year by respondents requesting formal dispute resolution under the guidance. In the **Federal Register** of October 24, 2005, (70 FR 61453), FDA announced the availability of the draft guidance and requested comments for 60 days on the information collection. No comments were received on this information collection. **Table 1.—Estimated Annual Reporting Burden** 1 Requests for Formal Dispute Resolution No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours CDER 8 1.25 10 8 80 CBER 1 1 1 8 8 Total 88 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 13, 2006. Jeffrey Shuren, Assistant Commssioner for Policy. [FR Doc. E6-763 Filed 1-23-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0021] Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols 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 information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the agency. DATES: Submit written or electronic comments on the collection of information by March 27, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . 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: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. 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. Request for Samples and Protocols (OMB Control Number 0910-0206)—Extension) Under section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to issue regulations that prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that the biologics licenses for such products are only issued when a product meets the prescribed standards. Under § 610.2 (21 CFR 610.2), FDA may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of applicable tests prior to marketing the lot of the product. In addition to § 610.2, there are other regulations that require the submission of samples and protocols for specific licensed biological products: §§ 660.6 (21 CFR 660.6) (Antibody to Hepatitis B Surface Antigen), 660.36 (21 CFR 660.36) (Reagent Red Blood Cells), and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen). Section 660.6(a) provides requirements for the frequency of submission of samples from each lot of Antibody to Hepatitis B Surface Antigen product, and § 660.6(b) provides the requirements for the submission of a protocol containing specific information along with each required sample. For § 660.6 products subject to official release by FDA, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history or manufacture of the product, including all results of each test for which test results are requested by the Center for Biologics Evaluation and Research (CBER). After official release is no longer required, one sample along with a protocol is required to be submitted at an interval of 90 days. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to FDA if continued evaluation is deemed necessary. Section 660.36(a) requires, after each routine establishment inspection by FDA, the submission of samples from a lot of final Reagent Red Blood Cell product along with a protocol containing specific information. Section 660.36(a)(2) requires that a protocol contain information including, but not limited to, manufacturing records, test records, and test results. Section 660.36

(b)requires a copy of the antigenic constitution matrix specifying the antigens present or absent to be submitted to FDA at the time of initial distribution of each lot. Section 660.46(a) provides requirements for the frequency of submission of samples from each lot of Hepatitis B Surface Antigen product, and § 660.46(b) provides the requirements for the submission of a protocol containing specific information along with each required sample. For § 660.46 products subject to official release by FDA, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history or manufacture of the product, including all results of each test for which test results are requested by CBER. After notification of official release is received, one sample along with a protocol is required to be submitted at an interval of 90 days. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to FDA if continued evaluation is deemed necessary. Samples and protocols are required by FDA to help ensure the safety, purity, or potency of the product because of the potential lot-to-lot variability of a product produced from living organisms. In cases of certain biological products ( *e.g.* , Albumin, Plasma Protein Fraction, and specified biotechnology and specified synthetic biological products) that are known to have lot-to-lot consistency, official lot release is not normally required. However, submissions of samples and protocols of these products may still be required for surveillance, licensing, and export purposes, or in the event that FDA obtains information that the manufacturing process may not result in consistent quality of the product. The following burden estimate is for the protocols that are required to be submitted with each sample. The collection of samples is not a collection of information under 5 CFR 1320.3(h)(2). Respondents to the collection of information under § 610.2 are manufacturers of licensed biological products. Respondents to the collection of information under §§ 660.6(b), 660.36(a)(2) and (b), and 660.46(b) are manufacturers of the specific products referenced previously in this document. The estimated number of respondents for each regulation is based on the annual number of manufacturers that submitted samples and protocols for biological products including submissions for lot release, surveillance, licensing, or export. Based on information obtained from FDA's database system, approximately 70 manufacturers submitted samples and protocols in fiscal year

(FY)2005, under the regulations cited previously in this document. FDA estimates that 65 manufacturers submitted protocols under § 610.2, and 4 manufacturers submitted protocols under the regulations (§§ 660.6 and 660.46) for the other specific products. FDA received no submissions under § 660.36, however FDA is using the estimate of one protocol submission in the event one is submitted in the future. The estimated total annual responses are based on FDA's final actions completed in FY 2005, which totaled 4,930, for the various submission requirements of samples and protocols for the licensed biological products. The rate of final actions is not expected to change significantly in the next few years. The hours per response are based on information provided by industry. The burden estimates provided by industry ranged from 1 to 5.5 hours. Under § 610.2, the hours per response are based on the average of these estimates and rounded to 3 hours. Under the remaining regulations, the hours per response are based on the higher end of the estimate (rounded to 5 or 6 hours) since more information is generally required to be submitted in the protocol than under § 610.2. FDA estimates the burden of this collection of information as follows: 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 610.2 65 74.1 4,816 3 14,448 660.6(b) 3 26 78 5 390 660.36(a)(2) and

(b)1 1 1 6 6 660.46(b) 1 35 35 5 175 Total 70 4,930 15,019 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-764 Filed 1-23-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0395] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 23, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act Products (OMB Control Number 0910-0429)—Extension This information collection approval request is for an FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of Prescription Drug User Fee Act (PDUFA) products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how the agency will interpret and apply section 119(a) of the Food and Drug Administration Modernization Act (the Modernization Act), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82 (21 CFR 312.47 and 312.82)). The guidance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at § 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2) describe information that should be submitted in support of a request for an End of Phase 2 meeting and a Pre New Drug Application

(NDA)meeting. The information collection provisions of § 312.47 have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting additional estimates for OMB approval. I. Request for a Meeting Under the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research

(CDER)or the Center for Biologics Evaluation and Research

(CBER)should submit a meeting request to the appropriate FDA component as an amendment to the underlying application. FDA regulations (§§ 312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information provided to the agency as part of an Investigational New Drug Application (IND), NDA, or Biological License Application

(BLA)must be submitted with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571, OMB control number 0910-0014; and FDA Form 356h, OMB control number 0910-0338, expires September 30, 2008. In the guidance document, CDER and CBER ask that a request for a formal meeting be submitted as an amendment to the application for the underlying product under the requirements of §§ 312.23, 314.50, and 601.2; therefore, requests should be submitted to the agency with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The agency recommends that a request be submitted in this manner for the following two reasons:

(1)To ensure that each request is kept in the administrative file with the entire underlying application, and

(2)to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the agency to monitor progress on the activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner. Under the guidance, the agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. Such information includes the following: • Information identifying and describing the product, • The type of meeting being requested, • A brief statement of the purpose of the meeting, • A list of objectives and expected outcomes from the meeting, • A preliminary proposed agenda, • A draft list of questions to be raised at the meeting, • A list of individuals who will represent the sponsor or applicant at the meeting, • A list of agency staff requested to be in attendance, • The approximate date that the information package will be sent to the agency, and • Suggested dates and times for the meeting. This information will be used by the agency to determine the utility of the meeting, to identify agency staff necessary to discuss proposed agenda items, and to schedule the meeting. II. Information Package A sponsor or applicant submitting an information package to the agency in advance of a formal meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or agency. The agency recommends that information packages generally include the following: • Identifying information about the underlying product; • A brief statement of the purpose of the meeting; • A list of objectives and expected outcomes of the meeting; • A proposed agenda for the meeting; • A list of specific questions to be addressed at the meeting; • A summary of clinical data that will be discussed (as appropriate); • A summary of preclinical data that will be discussed (as appropriate); and • Chemistry, manufacturing, and controls information that may be discussed (as appropriate). The purpose of the information package is to provide agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. Although FDA reviews similar information in the meeting request, the information package should provide updated data that reflect the most current and accurate information available to the sponsor or applicant. The agency finds that reviewing such information is critical to achieving a productive meeting. The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an End of Phase 2 meeting (§§ 312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre NDA meeting (§ 312.47(b)(2)). *Description of respondents* : A sponsor or applicant for a drug or biological product who requests a formal meeting with the agency regarding the development and review of a PDUFA product. *Burden Estimate* : Provided in the following paragraphs is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance. III. Request For a Formal Meeting Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 713 sponsors and applicants (respondents) request approximately 1,783 formal meetings with CDER annually and approximately 164 respondents request approximately 286 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA's experience, the agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting. IV. Information Package Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 615 respondents submitted approximately 1,365 information packages to CDER annually and approximately 132 respondents submitted approximately 208 information packages to CBER annually prior to a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the agency expects it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the agency. As stated earlier, the guidance provides information on how the agency will interpret and apply section 119(a) of the Modernization Act, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82). The information collection provisions in § 312.47 concerning End of Phase 2 meetings and Pre NDA meetings have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates. In the **Federal Register** of October 24, 2005 (70 FR 61445), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 Meeting Requests and Information Packages No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours Meeting Requests CDER 713 2.50 1,783 10 17,830 CBER 164 1.74 286 10 2,860 Total 20,690 Information Packages CDER 615 2.22 1,365 18 24,570 CBER 132 1.58 208 18 3,744 Total 28,314 Grand Total 49,004 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-765 Filed 1-23-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0296] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Good Laboratory Practice Regulations for Nonclinical Studies AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Good Laboratory Practice Regulations for Nonclinical Studies” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the Federal Register of January 4, 2005 (70 FR 364) the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0119. The approval expires on April 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: January 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-768 Filed 1-23-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Fogarty International Center; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, 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. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Fogarty International Center Advisory Board. *Date:* February 6-7, 2006. *Closed:* February 6, 2006, 1 p.m. to Adjournment. *Agenda:* To review and evaluate grant applications and proposals. *Place:* National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. *Open:* February 7, 2006, 8:30 a.m. to 5 p.m. *Agenda:* A report of the FIC Director on updates and overviews of new FIC initiatives. Topics to be discussed: The Disease Control Priorities Project: An Update. *Place:* National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. *Contact Person:* Jean L. Flagg-Newton, PhD, Special assistant to the Director, FIC, Fogarty International Center, National Institutes of Health, 9000 Rockville Pike, Building 31, Room B2C29, Bethesda, MD 20892.

(301)496-2968. *flaggnej@mail.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. 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 into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and sign-in at the security desk upon entering the building. Information is also available on the Institute's/Center's home page: *http://www.nih.gov/fic/about/advisory.html,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.106, Minority International Research Training Grant in the Biomedical and Behavioral Sciences; 93.154, Special International Postdoctoral Research Program in Acquired Immunodeficiency Syndrome; 93.168, International Cooperative Biodiversity Groups Program; 93.934, Fogarty International Research Collaboration Award; 93.989, Senior International Fellowship Awards Program, National Institutes of Health, HHS) Dated: January 11, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-652 Filed 1-23-06; 8:45 am]

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