Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols, 7546 [2016-02882]

Download as PDF 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 1 There 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] 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 https://www.reginfo.gov/ public/do/PRAMain. Dated: February 8, 2016. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–02882 Filed 2–11–16; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [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. 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 asabaliauskas on DSK9F6TC42PROD with NOTICES2 17:38 Feb 11, 2016 [Docket No. FDA–2016–N–0001] Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: SUMMARY: VerDate Sep<11>2014 Food and Drug Administration Jkt 238001 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. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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: https://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 https:// 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 E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 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 https://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

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