Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations, 78446-78447 [2014-30461]

Download as PDF 78446 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Prominent and Conspicuous Mark of Manufacturers On Single-Use Devices— (OMB Control Number 0910–0577)— Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. Section 301 of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107– 250) amended section 502 of the FD&C Act to add section 502(u) to require devices (both new and reprocessed) to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. Section 2(c) of the Medical Device User Fee Stabilization Act of 2005 (Pub. L. 109–43) amends section 502(u) of the FD&C Act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Under the amended provision, if the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol in a prominent and conspicuous manner on the device or attachment to the device. If the original SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may identify itself using a detachable label that is intended to be affixed to the patient record. The requirements of section 502(u) of the FD&C Act impose a minimal burden on industry. This section of the FD&C Act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 67 establishments that distribute approximately 427 reprocessed SUDs. Each response is anticipated to take 0.1 hours (6 minutes) resulting in a total burden to industry of 43 hours. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2 Number of disclosures per respondent Number of respondents Type of respondent Average burden per disclosure Total annual disclosures Total hours Establishments listing less than 10 SUDs. Establishments listing 10 or more SUDs. 58 2 116 0.1 (6 minutes) ................................. 12 9 34 306 0.1 (6 minutes) ................................. 31 Total ........................................... ........................ ........................ ........................ ........................................................... 43 1 There are no capital costs or operating and maintenance costs associated with this collection of information. have been rounded. 2 Numbers Dated: December 23, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30511 Filed 12–29–14; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1027] BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Infant Formula Recall Regulations’’ has SUMMARY: VerDate Sep<11>2014 21:42 Dec 29, 2014 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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. On October 27, 2014, the Agency submitted a proposed collection of information entitled ‘‘Infant Formula Recall Regulations’’ 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0188. The approval expires on November 30, 2017. A copy of the supporting statement for this information collection is available on the Internet at http:// www.reginfo.gov/public/do/PRAMain. Dated: December 22, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30461 Filed 12–29–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. These recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’, which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by March 2, 2015. ADDRESSES: Submit written requests for single copies of the individual BE guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:42 Dec 29, 2014 Jkt 235001 Ave., Hillandale Building, 4th floor, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE recommendations to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kris Andre Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4726, Silver Spring, MD 20993–0002, 240–402–7959. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received, and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on April 2, 2014 (79 FR 18561). This notice announces draft product-specific recommendations, either new or revised, that are posted on FDA’s Web site. product-specific BE recommendations for drug products containing the following active ingredients: TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS A ....... B ....... C ....... D ....... I ........ L ....... M ...... N ....... P ....... R ....... S ....... T ....... V ....... TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS A ....... B ....... D E H K M ....... ....... ....... ....... ...... N ....... FDA is announcing the availability of a new draft guidance for industry on S ....... Frm 00067 Fmt 4703 Sfmt 4703 Acetaminophen; Aspirin; Caffeine. Acetaminophen; Butalbital; Caffeine; Codeine phosphate. Acyclovir. Aripiprazole. Benzyl alcohol. Betamethasone valerate. Bosutinib monohydrate. Brimonidine tartrate; Brinzolamide. Buprenorphine hydrochloride; Naloxone hydrochloride. Cobicistat; Elvitegravir; Emtricitabine; Tenofovir disoproxil fumarate. Conjugated estrogens. Dapsone. Darunavir ethanolate. Ibuprofen sodium. Levothyroxine sodium (multiple reference listed drugs). Lidocaine; Prilocaine. Lomitapide mesylate. Lurasidone hydrochloride. Metoprolol tartrate. Nepafenac (multiple reference listed drugs). Posaconazole. Raltegravir potassium. Regorafenib. Selegine hydrochloride. Testosterone. Tofacitinib citrate. Treprostinil. Vandetanib. III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available PO 00000 78447 P ....... E:\FR\FM\30DEN1.SGM Adapalene (multiple reference listed drugs and dosage forms). Adapalene; Benzoyl peroxide. Brimonidine tartrate (multiple reference listed drugs). Brinzolamide. Doxorubicin hydrochloride. Ethinyl estradiol; Levonorgestrel. Hydrocodone bitartrate; Ibuprofen. Ketoconazole. Memantine hydrochloride (multiple dosage forms). Methylprednisolone acetate. Nebivolol hydrochloride. Nisoldipine. Phenytoin sodium (multiple reference listed drugs). Sevelamer carbonate. 30DEN1

Agencies

[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78446-78447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1027]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Infant Formula Recall Regulations

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 ``Infant Formula Recall 
Regulations'' 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 October 27, 2014, the Agency submitted a 
proposed collection of information entitled ``Infant Formula Recall 
Regulations'' 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

[[Page 78447]]

displays a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0188. 
The approval expires on November 30, 2017. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30461 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P