Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 17487 

Instructions and SPL resources may 

be found on the SPL Resources Web 

page at http://www.fda.gov/ForIndustry/ 

DataStandards/ 

StructuredProductLabeling/default.htm 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

New registrations, including new labeler codes requests ... 39 14.72 574 4.5 2,583 

Annual updates of registration information .......................... 3,256 2.99 9,735 4.5 43,808 

New drug listings ................................................................. 1,567 6.57 10,295 4.5 46,328 

New listings for private label distributor ............................... 146 10.06 1,469 4.5 6,611 

June and December updates of all drug listing information 1,677 11.21 18,799 4.5 84,596 

Waiver requests ................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 183,927 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity resulting from section 510(p) of the FD&C Act as 

amended by FDAAA 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

One-time preparation of SOP .............................................. 1,000 1 1,000 40 40,000 

SOP maintenance ................................................................ 3,295 1 3,295 1 3,295 

Total .............................................................................. ........................ ........................ ........................ ........................ 43,295 

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

Dated: March 20, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7136 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Antiviral Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Antiviral Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 11, 2012, from 8 a.m. to 5 

p.m. 

Location: DoubleTree by Hilton Hotel 

Washington DC/Silver Spring, The 

Ballrooms, 8727 Colesville Rd., Silver 

Spring, MD. The hotel telephone 

number is 301–589–5200. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

AVAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 203–100, 

for a fixed-dose combination tablet of 

elvitegravir/cobicistat/emtricitabine/ 

tenofovir disoproxil fumarate, submitted 

by Gilead Sciences, Inc. The application 

proposes an indication for the treatment 

of HIV–1 infection in adults who are 

antiretroviral naı ̈ve or have no known 

substitutions associated with resistance 

to the individual components. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 27, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 19, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 


tkelley on DSK3SPTVN1PROD with NOTICES
17488 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 20, 2012. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Yvette 

Waples at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/ucm111462.

htm for procedures on public conduct 

during advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 20, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7178 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Amendment to Proposed Collection: 

Comment Request Post-Award 

Reporting Requirements Including 

New Research Performance Progress 

Report Collection 

The 60-day Federal Register Notice 

for the proposed revision of information 

collection Public Health Service (PHS) 

Post-award Reporting Requirements, 

published March 5, 2012 (77 FR 13131), 

neglected to include the OMB 

information collection approval 

number. The number is OMB 0925– 

0002, expiration 06/30/2012. There are 

no additional corrections or changes to 

that Notice. 

Dated: March 15, 2012. 

Joe Ellis, 

Director, Office of Policy for Extramural 

Research Administration, Office of 

Extramural Research, National Institutes of 

Health. 

[FR Doc. 2012–7238 Filed 3–23–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Meeting 

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 

PubMed Central National Advisory 

Committee. 

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. 

Name of Committee: PubMed Central 

National Advisory Committee. 

Date: June 19, 2012. 

Time: 9:30 a.m. to 3 p.m. 

Agenda: Review and Analysis of Systems. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: David J. Lipman, M.D., 

Director, National Center for Biotechnology 

Information, National Library of Medicine, 

Building 38, Room 8N805, Bethesda, MD 

20894, 301–435–5985, 

dlipman@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 of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.pubmed.central.nih.gov/about/nac/ 

html, where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS.) 

Dated: March 20, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7240 Filed 3–23–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine ; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the meetings. 

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 materials, 

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: Biomedical Library 

and Informatics Review Committee 

Date: June 7–8, 2012. 

Time: June 7, 2012, 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Time: June 8, 2012, 8 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Contact Person: Arthur A. Petrosian, Ph.D., 

Chief Scientific Review Officer, Division of 

Extramural Programs, National Library of 

Medicine, 6705 Rockledge Drive, Suite 301, 

Bethesda, MD 20892–7968, 301–496–4253, 

petrosia@mail.nih.gov 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS.) 

Dated: March 20, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7239 Filed 3–23–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of a meeting of the 

Literature Selection Technical Review 

Committee. 

The meeting will be open to the 

public as indicated below, with 


tkelley on DSK3SPTVN1PROD with NOTICES