National Institute on Aging; Notice of Closed Meeting, 12643-12644 [2015-05454]

Download as PDF 12643 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 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. Reclassification Petitions for Medical Devices—21 CFR 860.123 (OMB Control Number 0910–0138)—Extension Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), subpart C, FDA has responsibility to collect data and information contained in reclassification petitions. The reclassification provisions of the FD&C Act allow any person to petition for reclassification of a device from any of the three classes, i.e., I, II, and III, to another class. The reclassification content regulation (§ 860.123) requires the submission of valid scientific evidence demonstrating that the proposed reclassification will provide a reasonable assurance of safety and effectiveness of the device type for its indications for use. The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a ‘‘Supplemental Data Sheet,’’ Form FDA 3427, and a ‘‘General Device Classification Questionnaire,’’ Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type. In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued a proposed rule that would eliminate the need for Forms FDA 3427 and FDA 3429. However, because the proposed rule has not been finalized, we continue to include the forms in the burden estimate for this information collection. The reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or to seek reclassification from a lower to a higher class, thereby increasing the regulatory requirements applicable to that device type. If approved, petitions requesting classification from class III to class II or class I provide an alternative route to market in lieu of premarket approval for class III devices. If approved, petitions requesting reclassification from class I or II, to a different class, may increase requirements. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent FDA Form Nos. Supporting data for reclassification petition ........................................................ Supplemental Data Sheet ........................ General Device Classification Questionnaire ...................................................... ........................ 3427 6 6 1 1 6 6 497 1.5 2,982 9 3429 6 1 6 1.5 9 Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000 mstockstill on DSK4VPTVN1PROD with NOTICES 1 There Number of respondents Average burden per response Activity Total annual responses Total hours are no capital costs or operating and maintenance costs associated with this collection of information. Based on reclassification petitions received in the last 3 years, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2) have consulted and advised manufacturers on these requirements, and (3) have reviewed the documentation submitted. This document refers to previously approved collections of information found in FDA regulations. These collections of information are subject to VerDate Sep<11>2014 17:53 Mar 09, 2015 Jkt 235001 review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120 and the collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910–0231. Dated: March 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–05506 Filed 3–9–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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 the discussions could disclose confidential trade secrets or commercial property such as patentable material, E:\FR\FM\10MRN1.SGM 10MRN1 12644 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Member Conflict SEP. Date: March 26, 2015. Time: 11:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ramesh Vemuri, Ph.D., Chief, Scientific Review Branch, National Institute On Aging, National Institutes Of Health, 7201 Wisconsin Avenue, Suite 2C– 212, Bethesda, MD 20892, 301–402–7700, rv23r@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: March 4, 2015. Melanie J. Gray, Program Analyst Office of Federal Advisory Committee Policy. [FR Doc. 2015–05454 Filed 3–9–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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 the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Ancillary R01 Telephone Review SEP. Date: April 3, 2015. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). VerDate Sep<11>2014 17:53 Mar 09, 2015 Jkt 235001 Contact Person: Xiaodu Guo, Md, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: March 4, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. Dated: March 4, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–05509 Filed 3–9–15; 8:45 am] [FR Doc. 2015–05446 Filed 3–9–15; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Centers for Disease Control and Prevention Office of the Director, National Institutes of Health Notice of Meeting [30 Day–15–14BAA] Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Office of AIDS Research Advisory Council. 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: Office of AIDS Research Advisory Council. Date: April 16, 2015. Time: 8:30 a.m. to 5:00 p.m. Agenda: The next meeting of the Office of AIDS Research Advisory Council (OARAC) will be devoted to presentations and discussions on ‘‘Maximizing U.S. Agency Partnerships for International HIV/AIDS Research.’’ An update will be provided on the latest changes made to the federal treatment and prevention guidelines by the OARAC Working Groups responsible for the guidelines. Place: National Institutes of Health, 5635 Fishers Lane Conference Center, Terrace Level, Suite T–500, Rockville, MD 20852. Contact Person: Amelia Hall, M.A., Program Analyst, Office of AIDS Research, Office of the Director, NIH, 5601 Fishers Lane, Room 2E63, Rockville, MD 20852, (240) 669–5462, hallam@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. Information is also available on the OAR’s home page: https:// www.oar.nih.gov. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 80, Number 46 (Tuesday, March 10, 2015)]
[Notices]
[Pages 12643-12644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
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 the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material,

[[Page 12644]]

and personal information concerning individuals associated with the 
grant applications, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Special Emphasis 
Panel; Member Conflict SEP.
    Date: March 26, 2015.
    Time: 11:00 a.m. to 12:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute on Aging, Gateway Building, Suite 
2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone 
Conference Call).
    Contact Person: Ramesh Vemuri, Ph.D., Chief, Scientific Review 
Branch, National Institute On Aging, National Institutes Of Health, 
7201 Wisconsin Avenue, Suite 2C-212, Bethesda, MD 20892, 301-402-
7700, rv23r@nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging 
Research, National Institutes of Health, HHS).

    Dated: March 4, 2015.
Melanie J. Gray,
Program Analyst Office of Federal Advisory Committee Policy.
[FR Doc. 2015-05454 Filed 3-9-15; 8:45 am]
 BILLING CODE 4140-01-P

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