7546 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 

forms that are equivalent. The State 

program maintains the documents and 

verifies records required for each 

standard. The information contained in 

the documents must be current and fitfor-use. If the State program fails to meet 

all program elements and 

documentation requirements of a 

standard, it develops a strategic plan 

which includes the following: (1) The 

individual element of documentation 

requirement of the standard that was not 

met, (2) improvements needed to meet 

the program element or documentation 

requirement of the standard, and (3) 

projected completion dates for each 

task. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

State Departments of Agriculture or Health ........................ 42 1 42 750 31,500 

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

The burden has been calculated as 

750 hours per respondent. This burden 

was determined by capturing the 

average amount of time for each 

respondent to assess the current state of 

the program and work toward 

implementation of each of the 10 

standards contained in MFRPS. The 

hours per respondent will change as 

accounted for in the continuing 

improvement and self-sufficiency of the 

program. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02888 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0114] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Request for Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Request for Samples and Protocols’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

September 24, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Request for 

Samples and Protocols’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0206. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02882 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–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 April 7, 2016, from 8 a.m. to 5 

p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Cindy Hong, 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, 

GIDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). 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 at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 207999, 

obeticholic acid oral tablets, submitted 

by Intercept Pharmaceuticals, Inc., 

proposed for the treatment of primary 

biliary cirrhosis in combination with 

ursodeoxycholic acid (UDCA) in adults 

with an inadequate response to UDCA 

or as monotherapy in adults unable to 

tolerate UDCA. 

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 


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