17078 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Gastrointestinal 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: Gastrointestinal 

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 31, 2012, from 8 a.m. to 

4:30 p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center (Rm. 1503), 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Minh Doan, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., WO31–2417, Silver 

Spring, MD 20993–0002, (301) 796– 

9001, Fax: (301) 847–8533, email: 

GIDAC@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 

hotline/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 200–436, 

synthetic human secretin, sponsored by 

Repligen Corporation, proposed for use 

with magnetic resonance imaging (MRI) 

to improve pancreatic duct visualization 

for the detection of duct abnormalities 

to enhance clinical decision making in 

patients with known or suspected 

pancreatitis. 

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 May 16, 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 May 8, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

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 May 9, 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 Minh Doan 

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 19, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6971 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance 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. 

Proposed Project: Patient Navigator 

Outreach and Chronic Disease 

Prevention Demonstration Program 

(OMB No. 0915–0346)—[Revision] 

This is a revision to a data collection 

previously approved for the Patient 

Navigator Outreach and Chronic Disease 

Prevention Demonstration Program 

(PNDP). Authorized under section 340A 

of the Public Health Service Act, as 

amended by Section 3510 of the Patient 

Protection and Affordable Care Act, 


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