[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Notices]
[Pages 14698-14699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0497]


Guidance for Industry on Pharmacogenomic Data Submissions; 
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 guidance for industry entitled ``Pharmacogenomic Data 
Submissions.'' The guidance provides recommendations to sponsors 
holding investigational new drug applications (INDs), new drug 
applications (NDAs), and biologics license applications (BLAs) on what 
pharmacogenomic data to submit to the agency during the drug 
development process, the format of submissions, and how the data will 
be used in regulatory decisionmaking. The guidance is intended to 
facilitate scientific progress in the area of pharmacogenomics.

DATES: Submit written or electronic comments on agency guidance 
documents 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, Food and Drug

[[Page 14699]]

Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Lawrence Lesko, Center for Drug Evaluation and Research (HFD-850), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-5690, or
    Raj Puri, Center for Biologics Evaluation and Research (HFM-735), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-0471.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Pharmacogenomic Data Submissions.'' Although the field of 
pharmacogenomics is in its infancy, the promise of pharmacogenomics 
lies in its potential to predict sources of interindividual variability 
in drug response (both efficacy and toxicity), thus allowing 
individualization of therapy to maximize effectiveness and minimize 
risk. Pharmaceutical sponsors have been reluctant to embark on programs 
of pharmacogenomic testing during the FDA-regulated phases of drug 
development, due to uncertainties in how FDA will react to the data 
being generated. This guidance is intended to facilitate scientific 
progress in the area of pharmacogenomics.
    The guidance is one of several efforts under way to facilitate 
pharmacogenomic testing. FDA will make available soon a concept paper 
entitled ``Concept Paper on Pharmacogenomic Drug Diagnostic Co-
Development.'' The concept paper is the first step in development of a 
draft guidance on that topic.
    On November 4, 2003 (68 FR 62461), FDA announced a document 
announcing the availability of the draft version of this guidance. A 
number of comments were received. The agency considered them carefully 
as it finalized the guidance and made appropriate changes. For the most 
part, the changes clarified statements made in the draft version. The 
following changes are noteworthy: (1) Appendix D (examples of 
pharmacogenomic data submissions) is no longer part of the guidance and 
has been moved into a separate document that will be available with the 
final guidance so that additional examples can be added over time; (2) 
a new appendix E has been added, a voluntary submission cover sheet, 
which should be used when submitting a ``voluntary'' genomic data 
submission to clearly distinguish such a submission from regular IND, 
NDA, or BLA submissions; (3) two fundamental issues regarding the 
procedure of submitting and reviewing voluntary genomic data 
submissions and the function and responsibilities of the 
Interdisciplinary Pharmacogenomics Review Group were addressed by 
creating separate internal agency procedures (i.e., the Center for Drug 
Evaluation and Research Manual of Policy and Procedures or the Center 
for Biologics Evaluation and Research Manual of Standard Operating 
Procedures and Policies) rather than including the information in the 
guidance document.

II. The Paperwork Reduction Act of 1995

    In the Federal Register of November 4, 2003 (68 FR 62461), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions of this guidance. In the Federal Register of 
August 11, 2004 (69 FR 48876), the agency announced that it was 
submitting the collection of information to the Office of Management 
and Budget (OMB) for review and clearance under the Paperwork Reduction 
Act of 1995. The information collection provisions related to this 
guidance have been approved under OMB control number 0910-0557. This 
approval expires December 31, 2007. 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.
    This level 1 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 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 statute, regulations, or 
both.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

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

    Dated: March 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5381 Filed 3-22-05; 8:45 am]
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