Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Human Tissue Intended for Transplantation, 7866 [2011-3031]

Download as PDF 7866 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Food and Drug Administration [FR Doc. 2011–3031 Filed 2–10–11; 8:45 am] In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–P [Docket No. 2010–N–0066] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Human Tissue Intended for Transplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Human Tissue Intended for Transplantation’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 7651, Juanmanuel.Vilela@fda.hhs.gov. In the Federal Register of August 2, 2010 (75 FR 45127), the Agency announced that the proposed information collection had been submitted 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 0910–0302. The approval expires on January 31, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Animal Drug User Fee Cover Sheet; FDA Form 3546—(OMB Control Number 0910–0539)—Extension DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0600] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet, Form 3546 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 14, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0539. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7651, Juanmanuel.vilela@fda.hhs.gov. SUMMARY: Under section 740 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-12), as amended by the Animal Drug User Fee Act (ADUFA), FDA has the authority to assess and collect for certain animal drug user fees. Because the submission of user fees concurrently with applications and supplements is required, review of an application cannot begin until the fee is submitted. The types of fees that require a cover sheet are certain animal drug application fees and certain supplemental animal drug application fees. The cover sheet (FDA Form 3546) is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application or supplement, to determine the amount of the fee required, and to assure that each animal drug user fee payment and each animal drug application for which payment is made is appropriately linked to the payment that is made. The form, when completed electronically, will result in the generation of a unique payment identification number used in tracking the payment. FDA will use the information collected to initiate administrative screening of new animal drug applications and supplements to determine if payment has been received. In the Federal Register of November 29, 2010 (75 FR 73103), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FD&C Act Section amended by ADUFA No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 740(a)(1) FDA Form 3546 (Cover Sheet) ........................... 76 1 76 1 76 ........................ ........................ ........................ ........................ 76 jlentini on DSKJ8SOYB1PROD with NOTICES Total .............................................................................. 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to this collection of information are new animal drug applicants or manufacturers. Based on FDA’s database system, there are an VerDate Mar<15>2010 18:55 Feb 10, 2011 Jkt 223001 estimated 140 manufacturers of products or sponsors of new animal drugs potentially subject to ADUFA. However, not all manufacturers or PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 sponsors will have any submissions in a given year and some may have multiple submissions. The total number of annual responses is based on the E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Page 7866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3031]



[[Page 7866]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2010-N-0066]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Human Tissue Intended for 
Transplantation

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 ``Human Tissue Intended for 
Transplantation'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, (301) 796-7651, Juanmanuel.Vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 2, 2010 
(75 FR 45127), the Agency announced that the proposed information 
collection had been submitted 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 0910-0302. 
The approval expires on January 31, 2014. 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 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3031 Filed 2-10-11; 8:45 am]
BILLING CODE 4160-01-P
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