[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
------------------------------------------------------------------------
21 CFR/ No. of Total annual Hours per
FDA Form respondents responses response Total hours
------------------------------------------------------------------------
601.2 343 84 1,600 134,400
Form 343 4,947 16 79,152
356h
Total 213,552
------------------------------------------------------------------------
\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\
------------------------------------------------------------------------
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
------------------------------------------------------------------------
\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