[Federal Register Volume 62, Number 49 (Thursday, March 13, 1997)]
[Notices]
[Pages 11899-11900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0192]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
April 14, 1997.
ADDRESSES: Submit written comments on the collection of information to
Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Linda L. Brna, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-3158.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the
following proposed collection of information to OMB for review and
clearance:
Application to Market a New Drug, Biologic, or an Antibiotic Drug
for Human Use; Use of Form FDA 356h
FDA is the Federal agency charged with the responsibility for
determining that drugs, including antibiotic drugs, and biologics are
safe and effective. Manufacturers of a drug, biologic, or an antibiotic
drug for human use must file applications for FDA approval of the
product prior to introducing it into interstate commerce. Statutory
authority for the collection of this information is provided by
sections 505(a), (b), and (j) and 507 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 355(a), (b), and (j) and 357) and
section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).
All manufacturers of new drugs and antibiotics for human use regulated
under the act must submit an application for review and approval to the
Center for Drug Evaluation and Research (CDER) or the Center for
Biologics Evaluation and Research (CBER) prior to marketing a drug or
antibiotic in interstate commerce (21 CFR 314.50). All manufacturers of
generic drugs, including generic antibiotic drugs for human use,
regulated under the act must submit an abbreviated new drug application
(ANDA) to CDER or CBER or an abbreviated antibiotic drug application
(AADA) to CDER for review and approval prior to marketing a generic
drug in interstate commerce (21 CFR 314.94). Most manufacturers of
biological products regulated under the PHS Act must submit an
establishment license application and a product license application or
a biologics license application for review and approval to CBER prior
to marketing a biological product in interstate commerce (21 CFR
601.2). Blood and blood components fall within the category of
biological products. All establishments collecting and/or preparing
blood and blood components for sale or distribution in interstate
commerce are subject to the licensing application provisions of section
351 of the PHS Act. Manufacturers of a drug, biologic, or an antibiotic
drug for human use are required to file supplemental applications for
all important changes to applications previously approved prior to
implementing such changes (21 CFR 314.70, 314.71, 314.97, and 601.12).
Form FDA 356h has been revised for CDER-regulated products to
include identification of different types of supplemental applications.
It has also been modified to include a section for establishment
information pertaining to CBER-regulated products and the CBER
licensing process.
The information provided by manufacturers with the revised
application form is necessary for FDA to carry out its mission of
protecting the public health and helping to ensure that drugs,
biologics, and antibiotics for human use have been shown to be safe and
effective. Form FDA 356h was developed initially as a checklist to
assist manufacturers in filing a drug application and has been
previously used only by manufacturers of products regulated under the
act. The revised form has been harmonized for use by manufacturers of
products regulated under the act or under the PHS Act and will be used
by industry regulated by both CDER and CBER. The harmonized application
form serves primarily as a checklist for firms to gather and submit to
the agency studies and data that have been completed. The checklist
helps to ensure that the application is complete and contains all the
necessary information, so that delays due to lack of information may be
eliminated. The form will also provide key information to the agency
for efficient handling and distribution to the appropriate staff for
review. The revised form will replace a number of different application
forms that are now used for these products and is intended to help
harmonize the application process.
In the Federal Register of October 1, 1996 (61 FR 51285), the
agency requested comments on the proposed collection of information
using the harmonized application form. FDA received five responses to
the docket, all of which were generally supportive of the harmonized
application form. One comment expressed concern that the requirement to
select a single supplement type on the form would result in an
increased reporting burden. The comment indicated that selection of a
single supplement type would require the filing of multiple supplements
in order to respond to an agency information request letter containing
several diverse issues. The comment may have misunderstood the
distinction between a supplement to an approved application and an
amendment to a pending application. A response to an agency information
request letter is an amendment to a pending application, no matter how
many individual subjects are addressed. This is clarified in the
instruction sheet for the form.
There were also a number of editorial comments on the form itself.
Some of these have resulted in minor modifications to the form. Other
editorial comments and requests for clarification are addressed in the
instructions for use of the form.
FDA estimates the burden of this collection of information as
follows:
[[Page 11900]]
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden
-----------------------------------------------------------------------------------------------------------------
Annual
Type of Response1 No. of Frequency per Total Annual Hours per Total Hours
Respondents2 Response3 Responses4 Response
----------------------------------------------------------------------------------------------------------------
NDA5 162 22.9 3,715 40 148,600
ANDA6 and AADA7 350 18.6 6,517 40 260,680
ELA8 and PLA9 391 4.9 1,905 40 76,200
Total Burden Hours 485,480
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.
\1\ Includes original applications and their amendments and supplemental applications
\2\ Number of sponsors submitting applications during fiscal year (FY) 95
\3\ Average number of applications submitted per sponsor
\4\ Total applications submitted during FY 95
\5\ New Drug Application (includes applications for new antibiotic drugs)
\6\ Abbreviated New Drug Application
\7\ Abbreviated Antibiotic Drug Application
\8\ Establishment License Application
\9\ Product License Application
In FY 95, CDER received a total of 10,232 submissions and CBER
received 1,905 submissions that would require use of this application
form. FDA estimates that 40 hours would be needed for an industry
regulatory affairs specialist to fill out the harmonized form, collate
the documentation, and submit the application to CDER or CBER.
Dated: March 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6360 Filed 3-12-97; 8:45 am]
BILLING CODE 4160-01-F
