Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices 10909 

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a draft guidance for industry entitled 

‘‘Medication Guides—Distribution 

Requirements and Inclusion of 

Medication Guides in Risk Evaluation 

and Mitigation Strategies (REMS).’’ This 

draft guidance is intended to address 

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 

healthcare professional. Questions have 

arisen concerning when a Medication 

Guide must be distributed with a drug 

or biological product dispensed to a 

healthcare 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 draft 

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 

draft guidance is when a Medication 

Guide 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 

(when the criteria in part 208 (21 CFR 

part 208) are met), the requirement for 

an applicant to develop a Medication 

Guide for distribution to each patient 

when the drug is dispensed. 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 a part of a 

REMS or 

(2) A Medication Guide in accordance 

with part 208 and section 505–1 of the 

FD&C Act that is part of a REMS, which 

will include other parts of a REMS (such 

as the timetable for submission of 

assessments) and possibly other REMS 

elements (including elements to assure 

safe use). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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 draft 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 §§ 314.70 and 600.12 

have been approved under OMB control 

numbers 0910–0001 and 0910–0338; 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 either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http:// 

www.regulations.gov. 

Dated: February 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4341 Filed 2–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Inherited 

Disease Research Access Committee. 

Date: March 15, 2011. 

Time: 11 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Ken D. Nakamura, PhD, 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, National Institutes of Health, 5635 

Fishers Lane, Suite 4076, MSC 9306, 

Rockville, MD 20852. 301–402–0838. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS). 

Dated: February 18, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–4304 Filed 2–25–11; 8:45 am] 

BILLING CODE 4140–01–P 


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