9342 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0053] 

Draft Guidance for Industry on Good 

Reprint Practices for the Distribution 

of Medical Journal Articles and 

Medical or Scientific Reference 

Publications on Unapproved New Uses 

of Approved Drugs and Approved or 

Cleared Medical Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Good Reprint 

Practices for the Distribution of Medical 

Journal Articles and Medical or 

Scientific Reference Publications on 

Unapproved New Uses of Approved 

Drugs and Approved or Cleared Medical 

Devices.’’ The draft guidance provides 

drug, biologics, and device 

manufacturers with the agency’s views 

on the distribution of medical journal 

articles and scientific or medical 

reference publications that discuss 

unapproved new uses for FDA approved 

drugs or biologics or FDA approved or 

cleared medical devices to health care 

professionals and health care entities. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 21, 2008. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Policy (HF–11), Office of 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit electronic requests for copies of 

the draft guidance to http:// 

www.fda.gov/oc/op/goodreprint.html. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jarilyn Dupont, Office of Policy, Office 

of Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3360. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Good Reprint Practices for the 

Distribution of Medical Journal Articles 

and Medical or Scientific Reference 

Publications on Unapproved New Uses 

of Approved Drugs and Approved or 

Cleared Medical Devices.’’ The draft 

guidance provides drug, biologics, and 

device manufacturers with the agency’s 

views on the distribution of medical 

journal articles and scientific or medical 

reference publications that discuss 

unapproved new uses for FDA approved 

drugs (including biologics) or FDA 

approved or cleared medical devices to 

health care professionals and health 

care entities. 

On September 30, 2006, section 401 of 

the Food and Drug Administration 

Modernization Act (FDAMA) (section 

551 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360aaa)) ceased 

to be in effect. The provision described 

certain conditions under which a drug 

or medical device manufacturer could 

disseminate medical and scientific 

information discussing unapproved uses 

of approved drugs and cleared or 

approved medical devices to health care 

professionals and certain entities 

(including pharmacy benefits managers, 

health insurance issuers, group health 

plans, and Federal or State 

governmental agencies). Section 401 of 

FDAMA provided that, if the described 

conditions were met, dissemination of 

such journal articles or reference 

publications would not be considered as 

evidence of the manufacturer’s intent 

that the product be used for an 

unapproved new use. FDA 

implementing regulations were codified 

at 21 CFR part 99. 

In light of the sunset of section 401 of 

FDAMA and in recognition of the public 

health value to health care professionals 

of receiving scientific and medical 

information, FDA is providing its 

current views and recommendations 

concerning ‘‘Good Reprint Practices’’ for 

the dissemination of medical journal 

articles and medical or scientific 

reference publications on unapproved 

uses of drugs and medical devices. 

FDA’s legal authority to determine 

whether distribution of medical or 

scientific information constitutes 

promotion of an unapproved ‘‘new use,’’

or whether such activities cause a 

product to be misbranded or adulterated 

has not changed. 

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 the dissemination of medical journal 

articles and medical or scientific 

reference publications on unapproved 

uses of approved drugs and approved or 

cleared medical devices to health care 

professionals and health care entities. 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) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Please note that as of January 15, 

2008, the FDA Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

submissions will be accepted by FDA 

only through FDMS. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: February 13, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 08–746 Filed 2–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

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. 3501 et seq.). To request a copy 


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