80 FR 12643 - National Institute on Aging; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 46 (March 10, 2015)

Page Range		12643-12644
FR Document		2015-05454

Federal Register, Volume 80 Issue 46 (Tuesday, March 10, 2015)

[Federal Register Volume 80, Number 46 (Tuesday, March 10, 2015)]
[Notices]
[Pages 12643-12644]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 12643

in 44 U.S.C. 3502(3) and 5 CFR respondents, including through the use Form FDA 3427, and a ‘‘General Device
1320.3(c) and includes Agency requests of automated collection techniques, Classification Questionnaire,’’ Form
or requirements that members of the when appropriate, and other forms of FDA 3429. Both forms contain a series
public submit reports, keep records, or information technology. of questions concerning the safety and
provide information to a third party. effectiveness of the device type.
Reclassification Petitions for Medical
Section 3506(c)(2)(A) of the PRA (44 In the Federal Register of March 25,
Devices—21 CFR 860.123 (OMB Control
U.S.C. 3506(c)(2)(A)) requires Federal 2014 (79 FR 16252), FDA issued a
Number 0910–0138)—Extension
Agencies to provide a 60-day notice in proposed rule that would eliminate the
the Federal Register concerning each Under sections 513(e) and (f), 514(b), need for Forms FDA 3427 and FDA
proposed collection of information, 515(b), and 520(l) of the Federal Food, 3429. However, because the proposed
including each proposed extension of an Drug, and Cosmetic Act (FD&C Act) (21 rule has not been finalized, we continue
existing collection of information, U.S.C. 360c(e) and (f), 360d(b), 360e(b), to include the forms in the burden
before submitting the collection to OMB and 360j(l)) and part 860 (21 CFR part estimate for this information collection.
for approval. To comply with this 860), subpart C, FDA has responsibility The reclassification provisions of the
requirement, FDA is publishing notice to collect data and information FD&C Act serve primarily as a vehicle
of the proposed collection of contained in reclassification petitions. for manufacturers to seek
information set forth in this document. The reclassification provisions of the reclassification from a higher to a lower
With respect to the following FD&C Act allow any person to petition class, thereby reducing the regulatory
collection of information, FDA invites for reclassification of a device from any requirements applicable to a particular
comments on these topics: (1) Whether of the three classes, i.e., I, II, and III, to device type, or to seek reclassification
the proposed collection of information another class. The reclassification from a lower to a higher class, thereby
is necessary for the proper performance content regulation (§ 860.123) requires increasing the regulatory requirements
of FDA’s functions, including whether the submission of valid scientific applicable to that device type. If
the information will have practical evidence demonstrating that the approved, petitions requesting
utility; (2) the accuracy of FDA’s proposed reclassification will provide a classification from class III to class II or
estimate of the burden of the proposed reasonable assurance of safety and class I provide an alternative route to
collection of information, including the effectiveness of the device type for its market in lieu of premarket approval for
validity of the methodology and indications for use. class III devices. If approved, petitions
assumptions used; (3) ways to enhance The reclassification procedure requesting reclassification from class I
the quality, utility, and clarity of the regulation requires the submission of or II, to a different class, may increase
information to be collected; and (4) specific data when a manufacturer is requirements.
ways to minimize the burden of the petitioning for reclassification. This FDA estimates the burden of this
collection of information on includes a ‘‘Supplemental Data Sheet,’’ collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
FDA Form Number of Total annual
Activity responses per burden per Total hours
Nos. respondents responses
respondent response

Supporting data for reclassification peti-
tion ........................................................ ........................ 6 1 6 497 2,982
Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9
General Device Classification Question-
naire ...................................................... 3429 6 1 6 1.5 9

Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on reclassification petitions review by the Office of Management and DEPARTMENT OF HEALTH AND
received in the last 3 years, FDA Budget (OMB) under the Paperwork HUMAN SERVICES
anticipates that six petitions will be Reduction Act of 1995 (44 U.S.C. 3501–
submitted each year. The time required 3520). The collections of information in National Institutes of Health
to prepare and submit a reclassification 21 CFR part 807, subpart E have been
petition, including the time needed to National Institute on Aging; Notice of
approved under OMB control number
assemble supporting data, averages 500 Closed Meeting
0910–0120 and the collections of
hours per petition. This average is based information in 21 CFR part 814, Pursuant to section 10(d) of the
upon estimates by FDA administrative subparts A through E have been Federal Advisory Committee Act, as
and technical staff who: (1) Are familiar approved under OMB control number amended (5 U.S.C. App.), notice is
with the requirements for submission of 0910–0231. hereby given of the following meeting.
a reclassification petition, (2) have
mstockstill on DSK4VPTVN1PROD with NOTICES

Dated: March 4, 2015. The meeting will be closed to the
consulted and advised manufacturers on public in accordance with the
these requirements, and (3) have Leslie Kux,
provisions set forth in sections
reviewed the documentation submitted. Associate Commissioner for Policy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
This document refers to previously [FR Doc. 2015–05506 Filed 3–9–15; 8:45 am]
as amended. The grant applications and
approved collections of information BILLING CODE 4164–01–P the discussions could disclose
found in FDA regulations. These confidential trade secrets or commercial
collections of information are subject to property such as patentable material,

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12644 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices

and personal information concerning Contact Person: Xiaodu Guo, Md, Ph.D., (Catalogue of Federal Domestic Assistance
individuals associated with the grant Scientific Review Officer, Review Branch, Program Nos. 93.14, Intramural Research
applications, the disclosure of which DEA, NIDDK, National Institutes of Health, Training Award; 93.22, Clinical Research
Room 761, 6707 Democracy Boulevard, Loan Repayment Program for Individuals
would constitute a clearly unwarranted Bethesda, MD 20892–5452, (301) 594–4719, from Disadvantaged Backgrounds; 93.232,
invasion of personal privacy. guox@extra.niddk.nih.gov. Loan Repayment Program for Research
Name of Committee: National Institute on (Catalogue of Federal Domestic Assistance Generally; 93.39, Academic Research
Aging Special Emphasis Panel; Member Program Nos. 93.847, Diabetes, Enhancement Award; 93.936, NIH Acquired
Conflict SEP. Endocrinology and Metabolic Research; Immunodeficiency Syndrome Research Loan
Date: March 26, 2015. 93.848, Digestive Diseases and Nutrition Repayment Program; 93.187, Undergraduate
Time: 11:00 a.m. to 12:30 p.m. Research; 93.849, Kidney Diseases, Urology Scholarship Program for Individuals from
Agenda: To review and evaluate grant and Hematology Research, National Institutes Disadvantaged Backgrounds, National
applications. of Health, HHS) Institutes of Health, HHS)
Place: National Institute on Aging, Dated: March 4, 2015.
Dated: March 4, 2015.
Gateway Building, Suite 2C212, 7201 Melanie J. Gray,
Wisconsin Avenue, Bethesda, MD 20892, David Clary,
(Telephone Conference Call). Program Analyst, Office of Federal Advisory Program Analyst, Office of Federal Advisory
Contact Person: Ramesh Vemuri, Ph.D., Committee Policy. Committee Policy.
Chief, Scientific Review Branch, National [FR Doc. 2015–05509 Filed 3–9–15; 8:45 am] [FR Doc. 2015–05446 Filed 3–9–15; 8:45 am]
Institute On Aging, National Institutes Of BILLING CODE 4140–01–P BILLING CODE 4140–01–P
Health, 7201 Wisconsin Avenue, Suite 2C–
212, Bethesda, MD 20892, 301–402–7700,
rv23r@nih.gov. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
(Catalogue of Federal Domestic Assistance HUMAN SERVICES HUMAN SERVICES
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS) National Institutes of Health Centers for Disease Control and
Dated: March 4, 2015. Prevention
Melanie J. Gray, Office of the Director, National
[30 Day–15–14BAA]
Institutes of Health Notice of Meeting
Program Analyst Office of Federal Advisory
Committee Policy. Agency Forms Undergoing Paperwork
Pursuant to section 10(a) of the
[FR Doc. 2015–05454 Filed 3–9–15; 8:45 am] Reduction Act Review
Federal Advisory Committee Act, as
BILLING CODE 4140–01–P amended (5 U.S.C. App.), notice is The Centers for Disease Control and
hereby given of a meeting of the Office Prevention (CDC) has submitted the
of AIDS Research Advisory Council. following information collection request
DEPARTMENT OF HEALTH AND The meeting will be open to the to the Office of Management and Budget
HUMAN SERVICES public, with attendance limited to space (OMB) for review and approval in
available. Individuals who plan to accordance with the Paperwork
National Institutes of Health
attend and need special assistance, such Reduction Act of 1995. The notice for
National Institute of Diabetes and as sign language interpretation or other the proposed information collection is
Digestive and Kidney Diseases; Notice reasonable accommodations, should published to obtain comments from the
of Closed Meeting notify the Contact Person listed below public and affected agencies.
in advance of the meeting. Written comments and suggestions
Pursuant to section 10(d) of the Name of Committee: Office of AIDS from the public and affected agencies
Federal Advisory Committee Act, as Research Advisory Council. concerning the proposed collection of
amended (5 U.S.C. App.), notice is Date: April 16, 2015. information are encouraged. Your
hereby given of the following meeting. Time: 8:30 a.m. to 5:00 p.m. comments should address any of the
The meeting will be closed to the Agenda: The next meeting of the Office of following: (a) Evaluate whether the
public in accordance with the AIDS Research Advisory Council (OARAC)
will be devoted to presentations and proposed collection of information is
provisions set forth in sections necessary for the proper performance of
discussions on ‘‘Maximizing U.S. Agency
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Partnerships for International HIV/AIDS the functions of the agency, including
as amended. The grant applications and Research.’’ An update will be provided on whether the information will have
the discussions could disclose the latest changes made to the federal practical utility; (b) Evaluate the
confidential trade secrets or commercial treatment and prevention guidelines by the accuracy of the agencies estimate of the
property such as patentable material, OARAC Working Groups responsible for the burden of the proposed collection of
and personal information concerning guidelines.
information, including the validity of
individuals associated with the grant Place: National Institutes of Health, 5635
Fishers Lane Conference Center, Terrace the methodology and assumptions used;
applications, the disclosure of which (c) Enhance the quality, utility, and
Level, Suite T–500, Rockville, MD 20852.
would constitute a clearly unwarranted Contact Person: Amelia Hall, M.A., clarity of the information to be
invasion of personal privacy. Program Analyst, Office of AIDS Research, collected; (d) Minimize the burden of
Name of Committee: National Institute of Office of the Director, NIH, 5601 Fishers the collection of information on those
Diabetes and Digestive and Kidney Diseases Lane, Room 2E63, Rockville, MD 20852, who are to respond, including through
Special Emphasis Panel; Ancillary R01 (240) 669–5462, hallam@mail.nih.gov. the use of appropriate automated,
Telephone Review SEP.
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Any interested person may file written electronic, mechanical, or other
Date: April 3, 2015. comments with the committee by forwarding technological collection techniques or
Time: 1:00 p.m. to 2:00 p.m. the statement to the Contact Person listed on
Agenda: To review and evaluate grant
other forms of information technology,
this notice. The statement should include the
applications. name, address, telephone number and when e.g., permitting electronic submission of
Place: National Institutes of Health, Two applicable, the business or professional responses; and (e) Assess information
Democracy Plaza, 6707 Democracy affiliation. Information is also available on collection costs.
Boulevard, Bethesda, MD 20892, (Telephone the OAR’s home page: http:// To request additional information on
Conference Call). www.oar.nih.gov. the proposed project or to obtain a copy

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Document Created: 2018-02-21 09:34:57
Document Modified: 2018-02-21 09:34:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		March 26, 2015.
FR Citation		80 FR 12643

80 FR 12643 - National Institute on Aging; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 46 (March 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health