[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)]
[Notices]
[Pages 49496-49497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0656]
Guidance for Industry on Submission of Abbreviated Reports and
Synopses in Support of Marketing Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Submission of
Abbreviated Reports and Synopses in Support of Marketing
Applications.'' This guidance, which implements section 118 of the Food
and Drug Administration Modernization Act of 1997 (Modernization Act),
is intended to assist applicants who wish to submit abbreviated reports
and synopses in lieu of full reports for certain clinical studies, both
in marketing applications for new products and in supplements to
approved applications. The guidance describes which studies may be
submitted as abbreviated reports or synopses and describes a format for
such submissions.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Copies of this 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. Submit written requests for single
copies of the guidance to the Drug Information Branch (HFD-210), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857 or the Manufacturers Assistance and
Communication Staff (HFM-42), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist that
office in processing your requests. Submit written comments on the
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857.
Comments are to be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Debbie J. Henderson, Center for Drug
Evaluation and Research (HFD-6), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-6779.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 21,
1998 (63 FR 50251), FDA announced the availability of a draft version
of this guidance for industry entitled ``Submission of Abbreviated
Reports and Synopses in Support of Marketing Applications.'' The agency
has finalized that draft guidance after considering comments received
on the draft version. Only few comments were received, and minor
changes were made to the draft version in an effort to make the
document clearer.
This guidance implements section 118 of the Modernization Act,
``Data requirements for drugs and biologics,'' which directs FDA to
issue guidance on when abbreviated study reports may be submitted in
new drug applications (NDA's) and biologics license applications
(BLA's) in lieu of full reports. Applicants have experienced
difficulties in the past in deciding when a full study report is
required by the reviewing body. For example, clinical drug and biologic
product development programs often include numerous clinical studies
and resulting data that are not intended to contribute to the
evaluation of the effectiveness of a product for a particular use and
are not needed to support information included
[[Page 49497]]
in labeling. Accordingly, such studies may be submitted as abbreviated
reports or synopses, and this guidance is intended to facilitate their
submission. This guidance is intended to provide guidance on the types
of studies that may be submitted in abbreviated reports or synopses.
The guidance also provides recommendations on the formats that should
be used.
In the Federal Register of September 21, 1998 (63 FR 50241), FDA
announced that it was submitting to the Office of Management and Budget
(OMB) for review and clearance under the Paperwork Reduction Act of
1995 (PRA) the collection of information entitled ``Application for FDA
Approval to Market a New Drug--21 CFR Part 314--(OMB Control Number
0910-0001).'' In that notice, FDA stated that the draft guidance
entitled ``Submission of Abbreviated Reports and Synopses in Support of
Marketing Applications'' (a notice announcing the availability of the
draft guidance was published in the same issue of the Federal Register)
would reduce the industry burden for submitting marketing applications
under Sec. #314.56 (21 CFR 314.50). FDA estimated that this reduction
in burden would be approximately 300 hours, and reduced the industry
burden estimate for Sec. 314.50 accordingly. The Federal Register
notice also requested comments on the burden estimates for part 314 (21
CFR part 314). OMB received no comments on the notice and approved the
information collection for part 314 until November 30, 2001. In
addition, none of the comments received in response to the notice
announcing the availability of the draft guidance pertained to
information collection issues under the PRA.
This guidance represents the agency's current thinking on
submission of full study reports, abbreviated reports, and synopses of
information related to effectiveness for new drugs and biological
products. 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, regulations, or both.
Interested persons may submit written comments on the guidance to
the Dockets Management Branch (address above). Two copies of any
comments are to be submitted, except that individuals may submit one
copy. The 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.
Dated: August 19, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-23663 Filed 9-10-99; 8:45 am]
BILLING CODE 4160-01-F
