80 FR 60395 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 193 (October 6, 2015)

Page Range		60395-60395
FR Document		2015-25317

Federal Register, Volume 80 Issue 193 (Tuesday, October 6, 2015)

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Page 60395]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Arthritis and Musculoskeletal and Skin 
Diseases; 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, 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: Arthritis and Musculoskeletal and Skin 
Diseases Initial Review Group; Arthritis and Musculoskeletal and 
Skin Diseases Clinical Trials Review Committee: AMSC-1 Clinical 
Trials Review Meeting.
    Date: October 27-28, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, 
Bethesda, MD 20817.
    Contact Person: Charles H. Washabaugh, Ph.D., Scientific Review 
Officer, Scientific Review Branch, NIAMS/NIH, 6701 Democracy 
Boulevard, Suite 816, Bethesda, MD 20892, 301-594-4952, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.846, 
Arthritis, Musculoskeletal and Skin Diseases Research, National 
Institutes of Health, HHS)

    Dated: September 30, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-25317 Filed 10-5-15; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60395

Generic Drug User Fee Cover Sheet; to calculate and pay generic drug user application and facility. Based on FDA’s
Form FDA 3794 OMB Control Number fees. Proposed Form FDA 3794, the database of application holders and
0910–0727—Extension Generic Drug User Fee Cover Sheet, related manufacturers, we estimate that
On July 9, 2012, the Generic Drug requests the minimum necessary approximately 460 companies would
User Fee Act (GDUFA) (Pub. L. 112– information to determine if a person has submit a total of 3,544 cover sheets
144, Title III) was signed into law by the satisfied all relevant user fee annually to pay for application and
President. GDUFA, designed to speed obligations. The proposed form is facility user fees. FDA estimates that the
the delivery of safe and effective generic modeled on other FDA user fee cover 3,544 annual cover sheet responses
drugs to the public and reduce costs to sheets, including Form FDA 3397, the would break down as follows: 1,439
industry, requires that generic drug Prescription Drug User Fee Act Cover facilities fees, 942 ANDAs, 502 PASs,
manufacturers pay user fees to finance Sheet. The information collected would and 661 Type II API DMFs. The
critical and measurable program be used by FDA to initiate the estimated hours per response are based
enhancements. The user fees required administrative screening of generic drug on FDA’s past experience with other
by GDUFA are as follows: (1) A one- submissions and DMFs, support the submissions and range from
time fee for original abbreviated new inspection of generic drug facilities, and approximately 0.1 to 0.5 hours. The
drug applications (ANDAs) pending on otherwise support the generic drug hours per response are estimated at the
October 1, 2012 (also known as backlog program. A copy of the proposed form upper end of the range to be
applications); (2) fees for type II active will be available in the docket for this conservative.
pharmaceutical ingredient (API) and notice.
Respondents to this proposed In the Federal Register of June 2, 2015
final dosage form (FDF) facilities; (3)
collection of information would be (80 FR 31388), FDA published a 60-day
fees for new ANDAs and prior approval
supplements (PASs); and (4) a one-time potential or actual generic application notice requesting public comment on
fee for drug master files (DMFs). holders and/or related manufacturers the proposed collection of information.
The purpose of this notice is to solicit (manufacturers of FDF and/or APIs). No comments were received.
feedback on the collection of Companies with multiple applications FDA estimates the burden of this
information in an electronic form used will submit a cover sheet for each collection of information as follows:

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

3794 .................................................. 460 7.7 3,544 0.5 (30 minutes) ............................... 1,772
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: September 30, 2015. Name of Committee: Arthritis and DEPARTMENT OF HEALTH AND
Leslie Kux, Musculoskeletal and Skin Diseases Initial HUMAN SERVICES
Associate Commissioner for Policy. Review Group; Arthritis and Musculoskeletal
[FR Doc. 2015–25360 Filed 10–5–15; 8:45 am] and Skin Diseases Clinical Trials Review National Institutes of Health
Committee: AMSC–1 Clinical Trials Review
BILLING CODE 4164–01–P
Meeting. National Institute of Neurological
Date: October 27–28, 2015. Disorders and Stroke; Notice of Closed
DEPARTMENT OF HEALTH AND Time: 8:00 a.m. to 5:00 p.m. Meetings
HUMAN SERVICES Agenda: To review and evaluate grant
applications. Pursuant to section 10(d) of the
National Institutes of Health Place: Bethesda Marriott Suites, 6711 Federal Advisory Committee Act, as
Democracy Boulevard, Bethesda, MD 20817. amended (5 U.S.C. App.), notice is
National Institute of Arthritis and Contact Person: Charles H. Washabaugh, hereby given of the following meetings.
Musculoskeletal and Skin Diseases; Ph.D., Scientific Review Officer, Scientific The meetings will be closed to the
Notice of Closed Meeting Review Branch, NIAMS/NIH, 6701 public in accordance with the
Democracy Boulevard, Suite 816, Bethesda, provisions set forth in sections
Pursuant to section 10(d) of the
MD 20892, 301–594–4952, washabac@
Federal Advisory Committee Act, as 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
mail.nih.gov.
amended (5 U.S.C. App.), notice is as amended. The grant applications and
hereby given of the following meeting. (Catalogue of Federal Domestic Assistance the discussions could disclose
The meeting will be closed to the Program Nos. 93.846, Arthritis, confidential trade secrets or commercial
public in accordance with the Musculoskeletal and Skin Diseases Research, property such as patentable material,
provisions set forth in sections National Institutes of Health, HHS) and personal information concerning
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Dated: September 30, 2015. individuals associated with the grant
as amended. The grant applications and applications, the disclosure of which
Carolyn Baum,
the discussions could disclose would constitute a clearly unwarranted
Program Analyst, Office of Federal Advisory
tkelley on DSK3SPTVN1PROD with NOTICES

confidential trade secrets or commercial invasion of personal privacy.
property such as patentable material, Committee Policy.
[FR Doc. 2015–25317 Filed 10–5–15; 8:45 am] Name of Committee: National Institute of
and personal information concerning Neurological Disorders and Stroke Special
individuals associated with the grant BILLING CODE 4140–01–P
Emphasis Panel; NINDS Research Resource
applications, the disclosure of which Opportunities Review.
would constitute a clearly unwarranted Date: November 2, 2015.
invasion of personal privacy. Time: 11:00 a.m. to 12:30 p.m.

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Document Created: 2015-12-15 08:51:39
Document Modified: 2015-12-15 08:51:39

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		October 27-28, 2015.
FR Citation		80 FR 60395

80 FR 60395 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 193 (October 6, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health