[Federal Register: April 8, 2004 (Volume 69, Number 68)]
[Notices]
[Page 18588-18590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap04-60]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0093]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Producers of Drugs and Listing of
Drugs in Commercial Distribution
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 requirements governing the
registration of producers of drugs and listing of drugs in commercial
distribution.
DATES: Submit written or electronic comments on the collection of
information by June 7, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(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: Karen L. Nelson, Office of Management
Programs (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
[[Page 18589]]
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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
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). Under Sec. 207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs
and biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter, are
required to register their establishment. In addition, manufacturers,
repackers, and relabelers are required to submit a listing of every
drug or biological product in commercial distribution. Owners or
operators of establishments that distribute, under their own label or
trade name, a drug product manufactured by a registered establishment
are not required to either register or list. However, distributors may
elect to submit drug listing information in lieu of the registered
establishment that manufactures the drug product. Foreign drug
establishments must also comply with the establishment registration and
product listing requirements if they import or offer for import their
products into the United States.
Under Sec. Sec. 207.21 and 207.22, establishments, both domestic
and foreign, must register with FDA by submitting Form FDA-2656
(Registration of Drug Establishment) within 5 days after beginning the
manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually by returning, within 30
days of receipt from FDA, Form FDA-2656e (Annual Update of Drug
Establishment). (Note: This form is no longer mailed to registrants by
FDA; updating registration information is estimated in table 1 of this
document by the information submitted annually on Form FDA-2656).
Changes in individual ownership, corporate or partnership structure
location, or drug-handling activity must be submitted as amendments to
registration under Sec. 207.26 within 5 days of such changes.
Distributors that elect to submit drug listing information must submit
Form FDA-2656 to FDA and a copy of the completed form to the registered
establishment that manufactured the product to obtain a labeler code.
Establishments must, within 5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a listing for every drug or
biological product in commercial distribution at that time by using
Form FDA-2657 (Drug Product Listing). Private label distributors may
elect to submit to FDA a listing of every drug product they place in
commercial distribution. Registered establishments must submit to FDA
drug product listing for those private label distributors who do not
elect to submit listing information by using Form FDA-2658 (Registered
Establishments' Report of Private Label Distributors).
Under Sec. 207.25, product listing information submitted to FDA by
domestic and foreign manufacturers must, depending on the type of
product being listed, include any new drug application number or
biological establishment license number, copies of current labeling and
a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the National Drug Code number, and any
drug imprinting information.
In addition to the product listing information required on Form
FDA-2657, FDA may also require, under Sec. 207.31, a copy of all
advertisements and a quantitative listing of all ingredients for each
listed drug or biological product not subject to an approved
application or license; the basis for a determination, by the
establishment, that a listed drug or biological product is not subject
to marketing or licensing approval requirements; and a list of certain
drugs or biological products containing a particular ingredient. FDA
may also request, but not require, the submission of a qualitative
listing of the inactive ingredients for all listed drugs or biological
products, and a quantitative listing of the active ingredients for all
listed drugs or biological products subject to an approved application
or license.
Under Sec. 207.30, establishments must update their product
listing information by using Form FDA-2657 and/or Form FDA-2658 every
June and December or, at the discretion of the establishment, when any
change occurs. These updates must include the following information:
(1) A listing of all drug or biological products introduced for
commercial distribution that have not been included in any previously
submitted list, (2) all drug or biological products formerly listed for
which commercial distribution has been discontinued, (3) all drug or
biological products for which a notice of discontinuance was submitted
and for which commercial distribution has been resumed, and (4) any
material change in any information previously submitted. No update is
required if no changes have occurred since the previously submitted
list.
FDA estimates the burden of this collection of information as
follows:
[[Page 18590]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/Form No. No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
FDA-2656 18,430 .36 6,700 2.50 16,750
(Registration of Drug
Establishment)
207.21
207.22
207.25
207.26
207.40
----------------------------------------------------------------------------------------------------------------
FDA-2656 8,382 .82 6,859 2.50 17,147.50
(Annual Update of Drug
Establishment)
207.21
207.22
207.25
207.26
207.40
----------------------------------------------------------------------------------------------------------------
FDA-2657 15,530 3 46,713 2.50 116,782.50
(Drug Product Listing)
207.21
207.22
207.25
207.30
207.31
207.40
----------------------------------------------------------------------------------------------------------------
FDA-2658 7,216 2.14 15,415 2.50 38,537.50
(Registered Establishments'
Report of Private Label
Distributors)
207.21
207.22
207.25
207.30
207.31
----------------------------------------------------------------------------------------------------------------
Total Reporting Burden .............. .............. .............. .............. 189,217.50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7907 Filed 4-7-04; 8:45 am]
BILLING CODE 4160-01-S