[Federal Register: March 23, 2005 (Volume 70, Number 55)]
[Notices]
[Page 14698-14699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr05-121]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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access to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-S