[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]                         

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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.

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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 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\
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                                                     Number of
     21 CFR Section/Form No.          No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
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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
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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
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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
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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
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Total Reporting Burden            ..............  ..............  ..............  ..............    189,217.50
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\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