[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Notices]
[Pages 52776-52777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22143]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1424]


Draft Guidance for Industry on Analytical Procedures and Methods 
Validation: Chemistry, Manufacturing, and Controls Documentation; 
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availability of a draft guidance for industry entitled ``Analytical 
Procedures and Methods Validation: Chemistry, Manufacturing, and 
Controls Documentation.'' This draft guidance is intended to provide 
recommendations to applicants on submitting analytical procedures, 
validation data, and samples to support the identity, strength, 
quality, purity, and potency of drug substances and drug products. The 
recommendations apply to drug substances and drug products covered in 
new drug applications (NDA's), abbreviated new drug applications 
(ANDA's), biologics license applications (BLA's), product license 
applications (PLA's), and supplements to these applications.

DATES: Submit written comments on the draft guidance by November 28, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry to the Drug Information Branch (HFD-210), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857; or to the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1488, FAX 888-CBERFAX or 301-827-3844. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. Submit written comments on the draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. To expedite FDA review of 
your comments to the docket on this draft guidance, CDER requests that, 
if possible, you also send an electronic copy of these comments by e-
mail to [email protected].

FOR FURTHER INFORMATION CONTACT:
    Radhika Rajagopalan, Center for Drug Evaluation and Research (HFD-
645), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-5849, or
    Alfred Del Grosso, Center for Biologics Evaluation and Research 
(HFM-250), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-435-4988.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Analytical Procedures and Methods Validation: Chemistry, 
Manufacturing, and Controls Documentation.'' This draft guidance is 
intended to assist applicants in assembling information, submitting 
samples, and presenting data to support analytical methodologies. The 
recommendations apply to drug substances and drug products covered in 
NDA's, ANDA's, BLA's, PLA's, and supplements to these applications. The 
principles also apply to drug substances and drug products covered in 
Type II drug master files.
    The principles of methods validation described in this guidance 
apply to all types of analytical procedures; however, the specific 
recommendations in this guidance may not be applicable to certain 
analytical procedures unique to products such as biological, 
biotechnological, botanical, or radiopharmaceutical drugs.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). It represents the 
agency's current thinking on analytical procedures and methods 
validation. 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 statute, regulations, or both.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the draft guidance by 
November 28, 2000. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be

[[Page 52777]]

identified with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of this draft guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm.

    Dated: August 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-22143 Filed 8-29-00; 8:45 am]
BILLING CODE 4160-01-F