[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]


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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.

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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.

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]]



                                                                                                                
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                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
        Type of Response1             No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Respondents2      Response3      Responses4       Response                   
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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       
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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