[Federal Register Volume 63, Number 67 (Wednesday, April 8, 1998)]
[Notices]
[Pages 17183-17184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0192]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The purpose of the proposed
collection of information is to enable manufacturers of biological
products to use specific establishment and product license application
(PLA) forms in submissions seeking FDA approval of their products.
DATES: Submit written comments on the collection of information by
April 20, 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. All comments should be identified with the docket
number found in brackets in the heading of this document.
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: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
PRA and 5 CFR 1320.13 because the information is essential to the
agency's mission. The agency cannot reasonably comply with the normal
clearance provisions of the PRA of 1995 because the use of normal
clearance procedures is reasonably likely to prevent or disrupt the
collection of information.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
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--Reinstatement)
FDA is the Federal agency charged with responsibility for insuring
the safety and effectiveness of drugs and the safety, purity, and
potency of biological products. 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, pure, and potent. The uniform format of the forms
provides for orderly, efficient review by
[[Page 17184]]
the Center for Biologics Evaluation and Review (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 this collection of
information is found in 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 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 impose additional standards relating to
certain information submitted 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 included with the burdens estimated for
Secs. 601.2 and 601.12 and cleared, together with application form
356h, under 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 biologics license applications (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
would 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
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.
Because all applicants have not completed the transition to Form
FDA 356h, this notice seeks clearance for the continued use of 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 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.
Under OMB control number 0910-0338, FDA estimated that CBER's
portion of the reporting burden for the 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. Thus, the other 73,200 hours would account for manufacturers
who have not completed the transition to using Form FDA 356h and who
still need to use the other license application forms described in this
notice. FDA expects that all manufacturers of biological products will
begin to use Form FDA 356h during 1998.
Dated: April 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9101 Filed 4-7-98; 8:45 am]
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