Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability, 71577-71578 [2011-29877]

Download as PDF 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 mstockstill on DSK4VPTVN1PROD with NOTICES 71578 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices will be required as part of a REMS. Under section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355–1(e)), FDA may require that a REMS for a drug include one or more of the elements described in section 505–1(e), including the requirement for an applicant to develop a Medication Guide for distribution to each patient when the drug is dispensed (when the criteria in part 208 (21 CFR part 208) are met). Since the enactment of the Food and Drug Administration Amendments Act of 2007, FDA has, as a matter of policy, considered any new Medication Guide (or safety-related changes to an existing Medication Guide) to be part of a REMS. However, the Agency has the authority to determine, based on the risks of a drug and public health concern, how a Medication Guide should be required when the standard in part 208 is met. Based on the risks and public health concern, the Agency may require: (1) A Medication Guide in accordance with part 208 that is not an element of a REMS or (2) A Medication Guide in accordance with part 208 and section 505–1 of the FD&C Act that is an element of a REMS, which may include other elements of a REMS (such as elements to assure safe use). In the Federal Register of February 28, 2011 (76 FR 10908), FDA announced the availability of a draft guidance for industry entitled ‘‘Medication Guides— Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’’ The notice gave interested parties the opportunity to comment by May 31, 2011. The Agency considered all of the comments received and made minor editorial and clarifying changes to the guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on when FDA intends to exercise enforcement discretion regarding Medication Guide distribution and inclusion of Medication Guides in REMS. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to VerDate Mar<15>2010 17:44 Nov 17, 2011 Jkt 226001 send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 314.70 and 601.12 have been approved under OMB control numbers 0910–0001 and 0910–0338, respectively; the collections of information in part 208 have been approved under OMB control number 0910–0393. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: November 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–29877 Filed 11–17–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To obtain a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Proposed Project: National Survey of Organ Donation Attitudes and Practices (OMB No. 0915–xxxx)—[New] The Division of Transplantation (DoT), Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), is planning to conduct a telephone survey of public knowledge, perceptions, opinion, and behaviors related to organ donation. Two key missions of the DoT are (1) to provide oversight for the Organ Procurement and Transplantation Network and policy development related to organ donation and transplantation and (2) to implement efforts to increase public knowledge about the need for increased organ donation. With a constantly growing deficit between the number of Americans needing donor organs (currently approximately 112,000) and the annual number of donors (14,505 in 2010), raising the American public’s willingness to donate becomes increasingly critical. Effective education and outreach campaigns need to be based on knowledge of the public’s attitudes and perceptions about, and perceived impediments to, organ donation. Two national surveys using nearly identical survey instruments to identify public views and behaviors related to organ donation were conducted in 1993 and 2005. The proposed study will identify current organ donation views and practices of the American public and various population subgroups using a survey instrument similar to the two earlier studies in order to track changes over time. It will measure issues such as public knowledge about and attitudes toward organ donation, public commitment to or willingness to donate, impediments to public willingness to donate, and attitudes toward living donation, donation practices, policy issues, allocation policy, presumed consent, and financial incentives for donation. Demographic information also will be collected. The randomly drawn sample will consist of 3,250 adults (age 18 and over), including an oversample of Asians, Hispanics, African Americans, and Native Americans, and will be geographically representative of the United States. The survey instrument will be administered in both English and Spanish through computerassisted telephone interviews. In addition to being useful to the DoT (especially in its donation outreach initiatives), results of this survey also will be of assistance to the donation and transplant community, DoT grantees and other research efforts, and to the E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71577-71578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29877]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0074]


Guidance for Industry on Medication Guide Distribution 
Requirements and Inclusion of Medication Guides in Risk Evaluation and 
Mitigation Strategies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: 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 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

[[Page 71578]]

will be required as part of a REMS. Under section 505-1(e) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355-
1(e)), FDA may require that a REMS for a drug include one or more of 
the elements described in section 505-1(e), including the requirement 
for an applicant to develop a Medication Guide for distribution to each 
patient when the drug is dispensed (when the criteria in part 208 (21 
CFR part 208) are met). Since the enactment of the Food and Drug 
Administration Amendments Act of 2007, FDA has, as a matter of policy, 
considered any new Medication Guide (or safety-related changes to an 
existing Medication Guide) to be part of a REMS. However, the Agency 
has the authority to determine, based on the risks of a drug and public 
health concern, how a Medication Guide should be required when the 
standard in part 208 is met. Based on the risks and public health 
concern, the Agency may require: (1) A Medication Guide in accordance 
with part 208 that is not an element of a REMS or (2) A Medication 
Guide in accordance with part 208 and section 505-1 of the FD&C Act 
that is an element of a REMS, which may include other elements of a 
REMS (such as elements to assure safe use).
    In the Federal Register of February 28, 2011 (76 FR 10908), FDA 
announced the availability of a draft guidance for industry entitled 
``Medication Guides--Distribution Requirements and Inclusion in Risk 
Evaluation and Mitigation Strategies (REMS).'' The notice gave 
interested parties the opportunity to comment by May 31, 2011. The 
Agency considered all of the comments received and made minor editorial 
and clarifying changes to the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on when FDA intends to exercise enforcement 
discretion regarding Medication Guide distribution and inclusion of 
Medication Guides in REMS. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314.70 and 601.12 have been 
approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively; the collections of information in part 208 have been 
approved under OMB control number 0910-0393.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29877 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P
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