[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65274-65276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32461]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0486]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 requirements governing the
registration of producers of drugs and listing of drugs in commercial
distribution.
DATES: Submit written comments on the collection of information by
February 9, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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
1320.39(c) and includes agency requests 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
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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.
Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution (21 CFR Part 207)--(OMB Control Number
0910-0045--Extension)
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360), FDA is authorized to establish a system for
registration of producers of drugs and for listing of drugs in
commercial distribution. To implement section 510 of the act, FDA
issued part 207 (21 CFR part 207). The regulations require an initial
listing of products and a twice-yearly update. In addition, all
registered drug firms are required to re-register annually between
January and July. The penalties for failure to register or drug list
are potential seizure and injunctions, as well as criminal enforcement
actions.
The following are the specific reporting requirements under part
207: (1) Section 207.20 requires that owners and operators of all drug
establishments that engage in the manufacture, preparation,
propagation, or processing of drugs must register and use Form FDA 2656
(Registration of Drug Establishment) and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors) to submit drug
listing information or to request a Labeler Code, or both. (2) Section
207.21 requires that owners and operators must register an
establishment within 5 days of beginning operations and shall complete
Form FDA 2656e (Annual Registration of Drug Establishment) each year
between January and July. Annual registration forms are mailed by the
FDA in each calendar year according to a schedule based on the
establishment parent company's name and must be completed within 30
days of the receipt. (3) Section 207.22(a) requires that Form FDA 2656
must be submitted when an establishment registers the first time. An
establishment whose drug registration is validated under Sec. 207.35(a)
is required to make subsequent annual registrations as described in
Sec. 207.21(a). (4) Section 207.22(b) requires that Form FDA 2657 must
be submitted for the first listing of drugs and subsequent June and
December updates. (5) Section 207.25 specifies the information required
in the establishment registration and drug listing. (6) Section
207.25(c) specifies the information about the drug that is required to
be submitted (name, active ingredients, dosage strength, NDC number,
manufacturer or distributor, size, shape, color, code imprint). (7)
Section 207.26 specifies the information required in the amendments to
the establishment registration. (8) Section 207.30 specifies the
information required for updating the drug listing. (9) Section 207.31
specifies additional drug listing information that may be needed beyond
that required in Secs. 207.25 and 207.30.
The information obtained from the establishment registration forms
FDA 2656 and FDA 2656(e) is used by FDA and other government agencies
to keep an accurate and current list of all human and animal drug
manufacturers, repackers, relabelers and other drug processors located
in this country. This list is used by FDA for inspectional purposes as
required by the act. In addition, the data is used by the public and
private sector as a listing of the names and locations of drug firms.
The information obtained from the listing forms FDA-2657 and FDA-2658
is used, through assignment of the National Drug Code numbers, for
third party reimbursement payment in Medicare and Medicaid as well as
other health care insurance firms.
Respondents to this collection of information are all owners and
operators that engage in the manufacture, preparation, propagation,
compounding, or processing of drugs and that are not exempt under
section 510(g) of the act or subpart D of 21 CFR 207.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
Form 21 CFR Section No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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Form FDA-2656
Registration of
Drug
Establishment 207.20
207.22
207.25
207.26 2,500 1 2,500 .5 1,250
Form FDA-2656(e)
Annual Re-
registration of
Drug
Establishments 207.21
207.25
207.26 9,000 1 9,000 .5 4,500
Form FDA-2657
Drug Product
Listing Form 207.22
207.30
207.31 45,000 1 45,000 .5 22,500
Form FDA-2658
Registered
Establishment's
Report of
Private Label
Distribution 207.20
207.21
207.25
207.26 6,200 1 6,200 .5 3,100
207.25(c) 1,500 12.04 18,066 .5 9,033
Total 40,383
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 65276]]
These estimates are based on FDA's Center for Drug Evaluation and
Research, Product Information Management Branch, and its data and
information on drug listing and establishment registration of
manufacturers, repackers, relabelers, and other drug processors.
Dated: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32461 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F