[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Pages 40584-40585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0157] (formerly Docket No. 2005D-0286)


Guidance for Industry: Current Good Manufacturing Practice for 
Phase 1 Investigational Drugs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: CGMP for 
Phase 1 Investigational Drugs'' dated July 2008. The guidance provides 
assistance in applying relevant current good manufacturing practice 
(CGMP) requirements of the Federal Food, Drug, and Cosmetic Act (the 
act) to the manufacture of most investigational new drugs, including 
biological drugs, used in phase 1 clinical trials. FDA is issuing this 
guidance concurrently with a final rule published elsewhere in this 
issue of the Federal Register specifying that compliance with FDA's 
CGMP regulations is not required for most investigational drugs that 
are manufactured for use in phase 1 clinical trials. Therefore, FDA is 
recommending the approaches outlined in this guidance for complying 
with the statutory CGMP requirements in the act. The guidance announced 
in this notice finalizes the draft guidance entitled ``INDs--Approaches 
to Complying with CGMP During Phase 1'' dated January 2006.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, or the Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive 
label to assist the office in processing your requests. The guidance 
may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-
827-1800. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

[[Page 40585]]

    Submit written comments on the 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.

FOR FURTHER INFORMATION CONTACT: Monica Caphart, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-9047, or Christopher 
Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food 
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448, 301-827-5000.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated 
July 2008. This guidance provides assistance in applying CGMP required 
under section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)) in the 
manufacture of most investigational new drugs used in phase 1 clinical 
trials (phase 1 investigational drugs). The guidance is being issued 
concurrently with a final rule that specifies that the manufacture of 
most investigational new drugs manufactured for use in phase 1 clinical 
trials do not have to comply with the specific regulatory requirements 
in part 211 (21 CFR part 211).
    Because a phase 1 clinical trial initially introduces an 
investigational new drug into human subjects, appropriate CGMP helps 
ensure subject safety. This guidance applies, as part of CGMP, quality 
control principles to the manufacture of phase 1 investigational drugs 
(i.e., interpreting and implementing CGMP consistent with good 
scientific methodology), which foster CGMP activities that are more 
appropriate for phase 1 clinical trials, improve the quality of phase 1 
investigational drugs, and facilitate the initiation of investigational 
clinical trials in humans while continuing to protect trial subjects. 
For the manufacture of phase 1 investigational drugs described in this 
guidance (see section III of the guidance), this guidance will replace 
the guidance issued in 1991 (56 FR 7048, February 21, 1991) entitled 
``Preparation of Investigational New Drug Products (Human and Animal)'' 
(the 1991 guidance). However, the 1991 guidance still applies to the 
manufacture of investigational new products (human and animal) used in 
phase 2 and phase 3 clinical trials.
    In the Federal Register of January 17, 2006 (71 FR 2552), FDA 
announced the availability of the draft guidance entitled ``INDs--
Approaches to Complying with CGMP During Phase 1'' dated January 2006. 
FDA received a moderate number of comments on the draft guidance and 
those comments were considered as the guidance was finalized. The 
guidance announced in this notice finalizes the draft guidance dated 
January 2006.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. 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. 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 this guidance for part 211 have been 
approved under OMB control number 0910-0139.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance. 
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. A copy of the guidance and 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 on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.regulations.gov.

    Dated: July 9, 2008.
Jeffrey Shuren,
Associate Comissioner for Policy and Planning.
[FR Doc. E8-16002 Filed 7-14-08; 8:45 am]
BILLING CODE 4160-01-S