Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient, 71576-71577 [2011-29837]

Download as PDF 71576 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by December 19, 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 emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0633. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300—(OMB Control Number 0910–0633)—Extension Under the Medical Device Amendments of 1976 (Pub. L. 94–295), class II devices were defined as those devices for which there was insufficient information to show that general controls themselves would provide a reasonable assurance of safety and effectiveness, but for which there was sufficient information to establish performance standards to provide such assurance. Condoms without spermicidal lubricant containing nonoxynol-9 are classified in class II. They were originally classified before the enactment of provisions of the Safe Medical Devices Act of 1990 (Pub. L. 101–629) that broadened the definition of class II devices and now permit FDA to establish special controls beyond performance standards, including guidance documents, to help provide reasonable assurance of the safety and effectiveness of such devices. In December 2000, Congress enacted Public Law 106–554, which among other provisions, directed FDA to ‘‘reexamine existing condom labels’’ and ‘‘determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness in preventing sexually transmitted diseases * * *.’’ In response, FDA recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against various types of sexually transmitted diseases. Respondents to this collection of information are manufacturers and repackagers of male condoms made of natural rubber latex without spermicidal lubricant. FDA expects approximately three new manufacturers or repackagers to enter the market yearly and collectively have a third-party disclosure burden of 1,224 hours. The number of respondents and prospective new manufacturers cited in table 1 of this document are based on FDA’s database of premarket submissions. The remaining figures were derived from a study performed for FDA by Eastern Research Group, Inc., an economic consulting firm, to estimate the impact of the 1999 over-the-counter (OTC) human drug labeling requirements final rule (64 FR 13254, March 17, 1999). Because the packaging requirements for condoms are similar to those of many OTC drugs, we believe the burden to design the labeling for OTC drugs is an appropriate proxy for the estimated burden to design condom labeling. The special controls guidance document also refers to currently approved collections of information found in FDA regulations. The collections of information under 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information under 21 CFR part 820 have been approved under OMB control number 0910–0073; and the collections of information in part 801 (21 CFR part 801) have been approved under OMB control number 0910–0485. The collection of information under § 801.437 does not constitute a ‘‘collection of information’’ under the PRA. Rather, it is a ‘‘public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public’’ (5 CFR 1320.3(c)(2)). In the Federal Register of July 8, 2011 (76 FR 40377), 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 THIRD-PARTY DISCLOSURE BURDEN 1 21 CFR section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 884.5300 .............................................................................. 3 34 102 12 1,224 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–29839 Filed 11–17–11; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0410] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 17:44 Nov 17, 2011 Jkt 226001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Premarket Notification for a New Dietary Ingredient’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– SUMMARY: E:\FR\FM\18NON1.SGM 18NON1 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 400B, Rockville, MD 20850, (301) 796– 3793. SUPPLEMENTARY INFORMATION: On August 25, 2011, the Agency submitted a proposed collection of information entitled ‘‘Premarket Notification for a New Dietary Ingredient’’ 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 0910–0330. The approval expires on November 30, 2013. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: November 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–P Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Followup Study for Infant Feeding Practices Study II’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 3793. SUPPLEMENTARY INFORMATION: On August 2, 2011, the Agency submitted a proposed collection of information entitled ‘‘Followup Study for Infant Feeding Practices Study II’’ 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 mstockstill on DSK4VPTVN1PROD with NOTICES Jkt 226001 Food and Drug Administration [Docket No. FDA–2011–D–0074] Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Medication Guides— Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’’ This guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the guidance addresses when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be provided with a drug or biological product that is dispensed to a health care professional for administration to a patient instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. Second, the guidance addresses when a Medication Guide will be required as part of a REMS. The guidance is intended to answer questions that have arisen concerning these topics. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or the SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Followup Study for Infant Feeding Practices Study II 17:44 Nov 17, 2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: [Docket No. FDA–2011–N–0099] VerDate Mar<15>2010 BILLING CODE 4160–01–P HHS. Food and Drug Administration SUMMARY: [FR Doc. 2011–29836 Filed 11–17–11; 8:45 am] AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Dated: November 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability [FR Doc. 2011–29837 Filed 11–17–11; 8:45 am] AGENCY: control number. OMB has now approved the information collection and has assigned OMB control number 0910–0696. The approval expires on November 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 71577 Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The guidance may also be obtained by mail by calling CBER at 1– (800) 835–4709 or (301) 827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: Kristen E. Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, (301) 796–5400; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852– 1448, (301) 827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’’ This guidance provides information for industry, health care providers, and authorized dispensers of prescription drug products. The guidance addresses two topics pertaining to Medication Guides for drug and biological products. Medication Guides are primarily for prescription drug and biological products used on an outpatient basis without direct supervision by a health care professional. Questions have arisen concerning when a Medication Guide must be provided with a drug or biological product that is dispensed to a health care professional for administration to a patient in certain situations, for example, in an inpatient setting or an outpatient setting such as a clinic or infusion center. This guidance is intended to articulate the circumstances under which FDA intends to exercise enforcement discretion regarding Medication Guide distribution. The second topic addressed by the guidance is when a Medication Guide E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71576-71577]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0410]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Premarket Notification for a New 
Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Premarket Notification for a New 
Dietary Ingredient'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-

[[Page 71577]]

400B, Rockville, MD 20850, (301) 796-3793.

SUPPLEMENTARY INFORMATION: On August 25, 2011, the Agency submitted a 
proposed collection of information entitled ``Premarket Notification 
for a New Dietary Ingredient'' 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 0910-0330. 
The approval expires on November 30, 2013. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29837 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P

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