[Federal Register: July 19, 2004 (Volume 69, Number 137)]
[Notices]               
[Page 42999-43001]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy04-77]                         

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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
----------------------------------------------------------------------------------------------------------------
(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
----------------------------------------------------------------------------------------------------------------
(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
----------------------------------------------------------------------------------------------------------------
(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
----------------------------------------------------------------------------------------------------------------
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