[Federal Register Volume 63, Number 172 (Friday, September 4, 1998)]
[Notices]
[Pages 47299-47300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23838]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0192]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Establishment and Product License
Applications: Forms FDA 2599, 2599a, 2600, 2600b, 3066, 3086, 3096,
3098, 3098a, 3098b, 3098c, 3098d, 3098e, 3210, 3213, 3214, and 3314
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 (the PRA).
DATES: Submit written comments on the collection of information by
October 5, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Establishment and Product License Applications: Forms FDA 2599,
2599a, 2600, 2600b, 3066, 3086, 3096, 3098, 3098a, 3098b, 3098c,
3098d, 3098e, 3210, 3213, 3214, and 3314--21 CFR 601.2 and 601.12--
(OMB Control Number 0910-0124--Extension)
FDA is the Federal agency charged with responsibility for
determining that drugs and biological products are safe and effective.
Manufacturers of biological products for human use must file an
application for FDA approval of the product prior to introducing it
into interstate commerce. The information provided by manufacturers on
these license application forms is necessary for FDA to carry out its
mission of protecting the public health and helping to ensure that
biologics for human use have been shown to be safe and effective. The
uniform format of the forms provides for orderly, efficient review by
the Center for Biologics Evaluation and Research (CBER) staff and
expedites the licensing process as well as documenting for future
reference the methods and procedures that have been approved for use at
each manufacturing location. Statutory authority for the collection of
this information is provided by section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262).
Section 601.2 (21 CFR 601.2) requires that manufacturers of
biological products regulated under the PHS Act submit an establishment
license application (ELA) and a product license application (PLA), or a
biologic license application (BLA) to CBER for review and approval
prior to marketing a biological product in interstate commerce. 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.
Section 601.12 (21 CFR 601.12) requires manufacturers of a biologic for
human use to file supplemental applications for all important changes
to applications previously approved prior to implementing such changes.
In addition to Secs. 601.2 and 601.12, other regulations provide
additional standards for human blood and blood products, which require
submission of certain information in a license application, including
21 CFR 640.17, 640.21(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a)
and (b)(2), and 680.1(b)(2)(iii) and (c). The information collection
requirements in the preceding regulations and their associated
reporting burdens are provided under the burden estimated for
Secs. 601.2 and 601.12 and the application form in approved OMB control
number 0910-0338.
As outlined in the President's November 1995 National Performance
Review's document entitled ``Reinventing the Regulation of Drugs Made
From Biotechnology,'' FDA intends to use a single harmonized
application form for all drug and licensed biological products. FDA
revised Form FDA 356h, ``Application to Market a New Drug, Biologic, or
an Antibiotic Drug for Human Use,'' for this purpose and announced its
availability in the Federal Register of July 8, 1997 (62 FR 36558).
This notice described FDA's intent to phase in the use of the new Form
FDA 356h for all biological products and stated that applicants
submitting new drug applications (NDA's), abbreviated new drug
applications (ANDA's), abbreviated antibiotic drug applications
(AADA's), and BLA's for biologic products specified in Sec. 601.2(c)
could begin to use the new Form FDA 356h immediately. The notice also
advised such applicants that they will be required to use revised Form
FDA 356h beginning January 8, 1998. In the interim period, the old Form
FDA 356h and the new Form FDA 356h were to be acceptable alternatives
for NDA's, ANDA's, AADA's, and BLA's.
In future Federal Register notices, FDA will advise applicants for
the products not yet using the new Form FDA 356h, when they may
voluntarily begin, and when they will be required to use the new Form
FDA 356h. FDA is in the process of preparing guidance documents on the
content and format of the chemistry, manufacturing, and controls
section, and establishment description section of the new Form FDA 356h
for those biological products not yet using the new form. As these
guidance documents are completed, FDA will begin accepting the new Form
[[Page 47300]]
FDA 356h. Until further notice, if the biological product is not
specified in Sec. 601.2(c), applicants should continue to submit an ELA
and a PLA application on the CBER forms listed below in this notice.
This collection of information involves the following forms:
Form FDA 2599, ``Establishment License Application for the Manufacture
of Blood and Blood Components;''
Form FDA 2599a, ``Supplement to Establishment License Application for
the Manufacture of Blood and Blood Components;''
Form FDA 2600, ``Product License Application for the Manufacture of
Source Plasma;''
Form FDA 2600b, ``Product License Application for Therapeutic Exchange
Plasma;''
Form FDA 3066, ``Product License Application for Manufacture of Blood
Grouping Reagents;''
Form FDA 3086, ``Product License Application for the Manufacture of
Reagent Red Blood Cells;''
Form FDA 3096, ``Product License Application for the Manufacture of
Anti-Human Globulin;''
Form FDA 3098, ``Product License Application for the Manufacture of
Whole Blood and Blood Components;''
Form FDA 3098a, ``Product License Application for Red Blood Cells;''
Form FDA 3098b, ``Product License Application for Plasma;''
Form FDA 3098c, ``Product License Application for Platelets;''
Form FDA 3098d, ``Product License Application for Cryoprecipitated
Antihemophilic Factor;''
Form FDA 3098e, ``The Manufacture of Products Prepared by
Cytapheresis;''
Form FDA 3210, ``Application for Establishment License for Manufacture
of Biological Products;''
Form FDA 3213, ``Application for License for the Manufacture of
Allergenic Products;''
Form FDA 3214, ``Application for the Manufacture of a Human Plasma
Derivative;'' and
Form FDA 3314, ``Product License Application for the Manufacture of
Human Immunodeficiency Virus for In-Vitro Diagnostic Use.''
Respondents to this collection of information are manufacturers of
biological products. The reporting burden for the current collection of
information using CBER's license application forms under OMB control
number 0910-0124 was reported to OMB as part of the total burden for
the agency's collection of information using Form FDA 356h. This
collection of information using Form FDA 356h was assigned OMB control
number 0910-0338 and approved by OMB on April 23, 1997. The approval
for OMB control number 0910-0338 expires on April 30, 2000. The
announcement of OMB's approval was published in the Federal Register of
May 19, 1997 (62 FR 27262).
Under OMB control number 0910-0338, FDA estimated that CBER's
portion of the reporting burden for collection of information using
Form FDA 356h was 76,200 hours. The 76,200 hours reflected the future
use of Form FDA 356h by all manufacturers of biological products. The
number of manufacturers of biological products that are already using
Form FDA 356h would account for approximately 3,000 hours of the total
burden hours. The other 73,200 hours would account for manufacturers
who may not have completed the transition to using Form FDA 356h and
still need to use other license application forms. FDA expects that all
manufacturers of biological products will begin to use Form FDA 356h
during 1998.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
21 CFR Section Forms No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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601.2 and 601.12 FDA 2599, 376 4.9 1,830 40 73,200
2599a, 2600,
2600b, 3066,
3086, 3096,
3098, 3098a,
3098b, 3098c,
3098d, 3098e,
3210, 3213,
3214, and
3314
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: August 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23838 Filed 9-3-98; 8:45 am]
BILLING CODE 4160-01-F
