[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]
BILLING CODE 4160-01-F