81 FR 7546 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

Page Range		7546-7546
FR Document		2016-02882

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.

Federal Register, Volume 81 Issue 29 (Friday, February 12, 2016)

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7546]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02882]


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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.

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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, [email protected].

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

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

forms that are equivalent. The State documentation requirements of a requirement of the standard, and (3)
program maintains the documents and standard, it develops a strategic plan projected completion dates for each
verifies records required for each which includes the following: (1) The task.
standard. The information contained in individual element of documentation FDA estimates the burden of this
the documents must be current and fit- requirement of the standard that was not collection of information as follows:
for-use. If the State program fails to meet met, (2) improvements needed to meet
all program elements and the program element or documentation

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

State Departments of Agriculture or Health ........................ 42 1 42 750 31,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden has been calculated as information entitled ‘‘Request for Location: FDA White Oak Campus,
750 hours per respondent. This burden Samples and Protocols’’ to OMB for 10903 New Hampshire Ave., Bldg. 31
was determined by capturing the review and clearance under 44 U.S.C. Conference Center, the Great Room (Rm.
average amount of time for each 3507. An Agency may not conduct or 1503), Silver Spring, MD 20993–0002.
respondent to assess the current state of sponsor, and a person is not required to Answers to commonly asked questions
the program and work toward respond to, a collection of information including information regarding special
implementation of each of the 10 unless it displays a currently valid OMB accommodations due to a disability,
standards contained in MFRPS. The control number. OMB has now visitor parking, and transportation may
hours per respondent will change as approved the information collection and be accessed at: http://www.fda.gov/
accounted for in the continuing has assigned OMB control number AdvisoryCommittees/
improvement and self-sufficiency of the 0910–0206. The approval expires on AboutAdvisoryCommittees/
program. December 31, 2018. A copy of the ucm408555.htm.
Dated: February 8, 2016. supporting statement for this Contact Person: Cindy Hong, Center
Leslie Kux, information collection is available on for Drug Evaluation and Research, Food
Associate Commissioner for Policy.
the Internet at http://www.reginfo.gov/ and Drug Administration, 10903 New
public/do/PRAMain. Hampshire Ave., Bldg. 31, Rm. 2417,
[FR Doc. 2016–02888 Filed 2–11–16; 8:45 am]
Dated: February 8, 2016. Silver Spring, MD 20993–0002, 301–
BILLING CODE 4164–01–P
Leslie Kux, 796–9001, FAX: 301–847–8533,
Associate Commissioner for Policy.
GIDAC@fda.hhs.gov, or FDA Advisory
DEPARTMENT OF HEALTH AND Committee Information Line, 1–800–
[FR Doc. 2016–02882 Filed 2–11–16; 8:45 am]
HUMAN SERVICES 741–8138 (301–443–0572 in the
BILLING CODE 4164–01–P
Washington, DC area). A notice in the
Food and Drug Administration Federal Register about last minute
modifications that impact a previously
[Docket No. FDA–2012–N–0114] DEPARTMENT OF HEALTH AND
announced advisory committee meeting
HUMAN SERVICES
Agency Information Collection cannot always be published quickly
Activities; Announcement of Office of Food and Drug Administration enough to provide timely notice.
Management and Budget Approval; Therefore, you should always check the
[Docket No. FDA–2016–N–0001] Agency’s Web site at http://
Request for Samples and Protocols
www.fda.gov/AdvisoryCommittees/
AGENCY: Food and Drug Administration, Gastrointestinal Drugs Advisory default.htm and scroll down to the
HHS. Committee; Notice of Meeting appropriate advisory committee meeting
ACTION: Notice. AGENCY: Food and Drug Administration, link, or call the advisory committee
HHS. information line to learn about possible
SUMMARY: The Food and Drug modifications before coming to the
Administration (FDA) is announcing ACTION: Notice.
meeting.
that a collection of information entitled This notice announces a forthcoming Agenda: The committee will discuss
‘‘Request for Samples and Protocols’’ meeting of a public advisory committee new drug application (NDA) 207999,
has been approved by the Office of of the Food and Drug Administration obeticholic acid oral tablets, submitted
Management and Budget (OMB) under (FDA). The meeting will be open to the by Intercept Pharmaceuticals, Inc.,
the Paperwork Reduction Act of 1995. public. proposed for the treatment of primary
FOR FURTHER INFORMATION CONTACT: FDA
asabaliauskas on DSK9F6TC42PROD with NOTICES2

Name of Committee: Gastrointestinal biliary cirrhosis in combination with
PRA Staff, Office of Operations, Food Drugs Advisory Committee. ursodeoxycholic acid (UDCA) in adults
and Drug Administration, 8455 General Function of the Committee: with an inadequate response to UDCA
Colesville Rd., COLE–14526, Silver To provide advice and or as monotherapy in adults unable to
Spring, MD 20993–0002, PRAStaff@ recommendations to the Agency on tolerate UDCA.
fda.hhs.gov. FDA’s regulatory issues. FDA intends to make background
SUPPLEMENTARY INFORMATION: On Date and Time: The meeting will be material available to the public no later
September 24, 2015, the Agency held on April 7, 2016, from 8 a.m. to 5 than 2 business days before the meeting.
submitted a proposed collection of p.m. If FDA is unable to post the background

VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1

Document Created: 2016-02-12 01:24:18
Document Modified: 2016-02-12 01:24:18

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
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 7546

81 FR 7546 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration