Proposed Information Collection Activity; Comment Request, 43436-43437 [05-14848]

Download as PDF 43436 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices Description: A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State’s Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) by the Council as planning document; (2) by the citizenry of the State as a mechanism for commenting on the plans of the Council; and (3) by the Department as a stewardship tool, for ensuring compliance with the Development Disabilities Assistance and Bill of Rights Act, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making. Respondents: State and Tribal Governments. ANNUAL BURDEN ESTIMATES Number of respondents Instrument State Plan on Developmental Disabilities ........................................................ Estimated Total Annual Burden Hours: 4,400. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: grjohnson@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments 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) Number of responses per respondent Average burden hours per response 1 80 55 the quality, utility, and clarity of the information to be collection; 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: July 21, 2005. Robert Sargis, Reports Clearance Officer. [FR Doc. 05–14847 Filed 7–26–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Total burden hours 4,400 OMB No.: 0980–0172. Description: A Developmental Disabilities Council Program Performance Report is required by federal statute. Each State Developmental Disabilities Council must submit an annual report for the preceding fiscal year of activities and accomplishments. Information provided in the Program Performance Report will be used (1) in the preparation of the biennial Report to the President, the Congress, and the National Council on Disabilities and (2) to provide a national perspective on program accomplishments and continuing challenges. This information will also be used to comply with requirements in the Government Performance and Results Act of 1993. Respondents: State and Tribal Governments. Proposed Projects Title: State Council on Developmental Disabilities Program Performance Report. ANNUAL BURDEN ESTIMATES Number of respondents Instrument State Council on Developmental Disabilities Program Performance Report .. Estimated Total Annual Burden Hours: 2,420. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 Frm 00047 Fmt 4703 Sfmt 4703 Average burden hours per response 1 44 55 information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: grjohnson@acf.hhs.gov. All requests PO 00000 Number of responses per respondent Total burden hours 2,420 should be identified by the title of the information collection. The Department specifically requests comments 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 E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: July 21, 2005. Robert Sargis, Reports Clearance Officer. [FR Doc. 05–14848 Filed 7–26–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002E–0344] (formerly Docket No. 02E–0344) Determination of Regulatory Review Period for Purposes of Patent Extension; ATS Open Pivot Bileaf Heart Valve AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ATS Open Pivot Bileaf Heart Valve and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory Policy (HFD–013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–453–6699. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA approved for marketing the medical device ATS Open Pivot Bileaf Heart Valve. ATS Open Pivot Bileaf Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ATS Open Pivot Bileaf Heart Valve (U.S. Patent No. 5,354,330) from ATS Medical, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated December 30, 2002, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of ATS Open Pivot Bileaf Heart Valve represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for ATS Open Pivot Bileaf Heart Valve is 1,418 days. Of this time, 980 days occurred during the testing phase of the regulatory review period, while 438 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act involving this device became effective: November 27, 1996. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 43437 FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) required under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) for human tests to begin became effective November 27, 1996. 2. The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e): August 3, 1999. FDA has verified the applicant’s claim that the premarket approval application (PMA) for ATS Open Pivot Bileaf Heart Valve (PMA P990046) was initially submitted August 3, 1999. 3. The date the application was approved: October 13, 2000. FDA has verified the applicant’s claim that PMA P990046 was approved on October 13, 2000. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 505 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by September 26, 2005. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 23, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 29, 2005. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 05–14748 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43436-43437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: State Council on Developmental Disabilities Program 
Performance Report.
    OMB No.: 0980-0172.
    Description: A Developmental Disabilities Council Program 
Performance Report is required by federal statute. Each State 
Developmental Disabilities Council must submit an annual report for the 
preceding fiscal year of activities and accomplishments. Information 
provided in the Program Performance Report will be used (1) in the 
preparation of the biennial Report to the President, the Congress, and 
the National Council on Disabilities and (2) to provide a national 
perspective on program accomplishments and continuing challenges. This 
information will also be used to comply with requirements in the 
Government Performance and Results Act of 1993.
    Respondents: State and Tribal Governments.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
State Council on Developmental Disabilities                   55               1              44           2,420
 Program Performance Report.....................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 2,420.
    In compliance with the requirements of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Administration, Office of Information Services, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail 
address: grjohnson@acf.hhs.gov. All requests should be identified by 
the title of the information collection.
    The Department specifically requests comments 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

[[Page 43437]]

proposed collection of information; (c) 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. Consideration will be given to comments and 
suggestions submitted within 60 days of this publication.

    Dated: July 21, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05-14848 Filed 7-26-05; 8:45 am]
BILLING CODE 4184-01-M