[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