[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Notices]
[Pages 4979-4981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4202]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Application to Market a New Drug, Biologic, or 
an Antibiotic Drug for Human Use--Form FDA 356h

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 
March 3, 2000.

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: 
Wendy Taylor, 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 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; Form FDA 356h (OMB Control Number 0910-0338)--
Extension

    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, or biologic 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 section 505(a), (b), and 
(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
355(a), (b), and (j)) and section 351 of the Public Health Service Act 
(the PHS Act) (42 U.S.C. 262). Manufacturers of new drugs for human use 
regulated under the act must submit

[[Page 4980]]

a new drug application (NDA) for review and approval to the Center for 
Biologics Evaluation and Research (CBER) or the Center for Drug 
Evaluation and Research (CDER) prior to marketing a drug in interstate 
commerce (Sec. 314.50 (21 CFR 314.50)). Manufacturers of generic drugs 
regulated under the act must submit an abbreviated new drug application 
(ANDA) for review and approval to CDER prior to marketing a generic 
drug in interstate commerce (Sec. 314.94 (21 CFR 314.94)). 
Manufacturers of biological products regulated under the PHS Act must 
submit an establishment license application (ELA) and a product license 
application (PLA) or biologics license application (BLA) for review and 
approval to CBER prior to marketing a biological product in interstate 
commerce (Sec. 601.2 (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. Applicants are 
required to report to FDA any transfer of ownership of an NDA (21 CFR 
314.72). Applicants are required to report a change in ownership of an 
ANDA (21 CFR 314.99(a)). Manufacturers of a drug or biologic for human 
use are required to file supplemental applications for certain changes 
to applications previously approved (Secs. 314.70, 314.71, 314.97, and 
601.12 (21 CFR 314.70, 314.71, 314.97, and 601.12)). The form is also 
submitted with an amendment to an unapproved original application or 
supplemental application, and a presubmission or resubmission of 
information pertaining to an application. The information provided by 
manufacturers with the application form is necessary for FDA to carry 
out its mission of protecting the public health and helping to ensure 
that drugs and biologics for human use have been shown to be safe and 
effective. Form FDA 356h was developed initially as a checklist to 
assist manufacturers in filling out a drug application and has been 
previously used only by manufacturers of products regulated under the 
act. In the Federal Register of July 8, 1997 (62 FR 36558), FDA 
announced the availability of the revised Form FDA 356h. The form was 
revised as a ``Reinventing Government'' initiative to harmonize 
application procedures between CBER and CDER. The 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 provides key information to the agency for 
efficient handling and distribution to the appropriate staff for 
review. For biologics manufacturers, the form will replace a number of 
different ELA and PLA forms that were formerly used for these products. 
The information collection burden for various ELA and PLA forms is 
covered under OMB Control No. 0910-0124. There are an estimated 343 
licensed biologics manufacturers. However, not all manufacturers will 
have any submissions in a given year and some may have multiple 
submissions. The annual responses are based on submissions received by 
FDA in 1998. The time estimated to prepare an ELA, PLA, or BLA under 
Sec. 601.2 for CBER approval to market a new product is based on 
information provided by industry. The time required for preparing an 
ELA, PLA, or BLA includes the estimate for filling out the form. The 
estimated average burden hours for the other submissions using Form 
356h to CBER is based on past FDA experience and includes the time to 
fill out the form and collate the documentation. The average burden 
hours also include the time to prepare an amendment submitted to CBER. 
The estimated burden hours to prepare a supplement to CBER 
(Sec. 601.12) are reported under OMB Control No. 0910-0315.
    In the Federal Register of October 21, 1999 (64 FR 56797), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

       Table 1.--Estimated Annual Reporting Burden for Biologics 1
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 21 CFR
Section/      No. of       Total annual      Hours per      Total hours
FDA form    respondents      responses       response
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601.2         343              84           1,600         134,400
Form FDA      343           4,947              16          79,152
 356h
Total                                                     213,552
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    There are 483 drug applicants that submitted the form. The annual 
responses are based on submissions received by FDA in 1997 and 1998. 
The estimated average burden hours for the submissions using Form 356h 
to CDER is based on past FDA experience and includes the time to fill 
out the form and collate the documentation. The estimated burden hours 
to prepare an NDA (Sec. 314.50); an ANDA (Sec. 314.94); supplements 
(Secs. 314.70, 314.71, and 314.97); and amendments (21 CFR 314.60 and 
314.96) are approved under OMB Control No. 0910-0001.
    FDA estimates the burden of this collection of information as 
follows:

      Table 2.--Estimated Annual Reporting Burden for Human Drugs 1
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   FDA        No. of       Total Annual      Hours per
  form      respondents      responses       response       Total hours
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Form FDA      483          16,221              24         389,304
 356h
Total                                                     389,304
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.



[[Page 4981]]

    Dated: January 24, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-2150 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F