[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 42999-43001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0093]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
18, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug
[[Page 43000]]
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.
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.
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 either to 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 the table below
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 a 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:
Table 1.--Estimated Reporting Burden\1\
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21 CFR Number of
Section/Form No. of Respondents ResponsesPer Total Annual Hours per Total Hours
No. Respondent Responses Responses
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(1) Form FDA- 18,430 .36 6,700 2.50 hr. 16,750
2656
Registration
of Drug
Establishme
nt
21 CFR
207.21
21 CFR
207.22
21 CFR
207.25
21 CFR
207.26
21 CFR
207.40
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[[Page 43001]]
(2) Form FDA- 8,382 .82 6,859 2.50 hr. 17,147.50
2656
Annual
Update of
Drug
Establishme
nt
21 CFR
207.21
21 CFR
207.22
21 CFR
207.25
21 CFR
207.26
21 CFR
207.40
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(3) Form FDA- 15,530 3 46,713 2.50 hr. 116,782.50
2657
Drug Product
Listing
21 CFR
207.21
21 CFR
207.22
21 CFR
207.25
21 CFR
207.30
21 CFR
207.31
21 CFR
207.40
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(4) Form FDA- 7,216 2.14 15,415 2.50 hr. 38,537.50
2658
Registered
Establishme
nts' Report
of Private
Label
Distributor
s
21 CFR
207.21
21 CFR
207.22
21 CFR
207.25
21 CFR
207.30
21 CFR
207.31
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Total .................. .................. .................. .................. 189,217.50
Reporting
Burden
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In the Federal Register of April 8, 2004 (69 FR 18588), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: July 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16305 Filed 7-16-04; 8:45 am]
BILLING CODE 4160-01-S