Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees, 46272 [2014-18609]

Download as PDF 46272 Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Section; activity Average burden per disclosure Total annual disclosures Total hours 107.230; Elements of infant formula recall .......................... 107.260; Revision of an infant formula recall ...................... 2 1 1 1 2 1 50 25 100 25 Total .............................................................................. ........................ ........................ ........................ ........................ 125 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2 reports FDA’s third-party disclosure burden estimates for §§ 107.230 and 107.260. The estimated burden hours per disclosure is an average based on FDA’s experience. The third-party disclosure burden in § 107.230 is the requirement to promptly notify each affected directaccount (customer) about the recall, and if the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post a notice of the recall at the point of purchase. FDA estimates that 2 respondents will conduct infant formula recalls under § 107.230 and that it will take a respondent 50 hours to comply with the third-party disclosure requirements of that section, for a total of 100 hours. The third-party disclosure burden in § 107.260 is the requirement to issue additional notifications where the recall strategy or implementation is determined to be deficient. FDA estimates that 1 respondent will issue additional notifications under § 107.260 and that it will take a respondent 25 hours to comply with the third-party disclosure requirements of that section, for a total of 25 hours. Dated: August 1, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Radioactive Drug Research Committees’’ 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 May 9, 2014, the Agency submitted a proposed collection of information entitled ‘‘Radioactive Drug Research Committees’’ 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 0910–0053. The approval expires on July 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: Dated: July 31, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18665 Filed 8–6–14; 8:45 am] [FR Doc. 2014–18609 Filed 8–6–14; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2007–N–0383] emcdonald on DSK67QTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2014–N–1088] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees Center for Devices and Radiological Health: Experiential Learning Program; General Training Program AGENCY: Food and Drug Administration, HHS. ACTION: 17:14 Aug 06, 2014 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for SUMMARY: Notice. VerDate Mar<15>2010 AGENCY: Jkt 232001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Devices and Radiological Health (CDRH or Center) is announcing a new component of the Experiential Learning Program (ELP) identified as the ELP General Training Program. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the ELP General Training Program. DATES: Submit either an electronic or written request for participation in the ELP General Training Program by September 8, 2014. ADDRESSES: Submit either electronic requests to https://www.regulations.gov or written requests to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify proposals with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993–0002, 301–796–6965, FAX: 301–827–3079, Latonya.powell@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices and safe radiation-emitting products. In support of this mission, the Center launched various training and development initiatives to enhance performance of its staff involved in regulatory review and E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Page 46272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0383]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Radioactive Drug Research Committees

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 ``Radioactive Drug Research
Committees'' 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 May 9, 2014, the Agency submitted a
proposed collection of information entitled ``Radioactive Drug Research
Committees'' 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 0910-0053. The approval
expires on July 31, 2017. A copy of the supporting statement for this
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

Dated: July 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18609 Filed 8-6-14; 8:45 am]
BILLING CODE 4164-01-P

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