[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Notices]
[Pages 56797-56799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4202]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the application form, 
Application to Market a New Drug, Biologic, or an Antibiotic Drug for 
Human Use, Form FDA 356h, and a related regulation. This form applies 
to a wide range of products for human use that are regulated by both 
the Center for Biologics Evaluation and Research (CBER) and the Center 
for Drug Evaluation and Research (CDER) including drugs and biologics.

DATES: Submit written comments on the collection of information by 
December 20, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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

[[Page 56798]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency request or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    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.

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 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 
(PHS Act) (42 U.S.C. 262). Manufacturers of new drugs for human use 
regulated under the act must submit a new drug application (NDA) for 
review and approval to CBER or 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 a 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 (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 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.
    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/      No. of       Total annual      Hours per
FDA Form    respondents      responses       response       Total hours
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601.2         343              84           1,600         134,400
Form          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.


[[Page 56799]]

    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 (21 
CFR 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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 21 CFR
Part/FDA      No. of       Total annual      Hours per      Total hours
  Form      respondents      responses       response
------------------------------------------------------------------------
Form          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.


    Dated: October 13, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-27499 Filed 10-20-99; 8:45 am]
BILLING CODE 4160-01-F