[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48656-48658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0323]


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 October 23, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
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: Elizabeth Berbakos, Office of the 
Chief Information Officer (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 
1320.3(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 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 current\1\ 21 CFR 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.
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    \1\This notice requests comments on the information collection 
in current part 207. In the Federal Register of Augst 29, 2006 (71 
FR 51276), FDA proposed to revise part 207. The proposed revisions 
would reorganize, consolidate, clarify, and modify current 
regulations concerning who must register establishments and list, 
and describes when and how to register and list and what information 
must be submitted for registration and listing. In addition, the 
proposal would make certain changes to the National Drug Code (NDC) 
system and would require the appropriate NDC number to appear on the 
labels for drugs subject to the listing requirements. The proposed 
regulations generally also require the electronic submission of all 
registration and most listing information. The August 29, 2006, 
proposed rule requested comments on the information collection for 
revised part 207. When the proposal is finalized, the information 
collection for revised part 207 will replace the information 
collection in this notice.
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    Under current 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

[[Page 48657]]

structure, location, or drug-handling activity must be submitted as 
amendments to registration under current 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 current 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 current 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 current 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 annual information collection burden for current 
part 207 as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                          Number of
       Form              No. of         responses per       Total annual        Hours per         Total hours
                      respondents         respondent         responses           response
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(1) Form FDA-2656                 39              14.72                574               2.50              1,435
 - Registration
 of Drug
 Establishment
 (New
 registrations,
 including new
 labeler codes
 for private
 label
 distributors)
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(2) Form FDA-2656              3,256               2.99              9,763               2.50          24,407.50
 - Annual Update
 of Drug
 Establishment
 (Update of
 registration
 information)
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(3) Form FDA-2657              1,567               6.57             10,301               2.50          25,752.50
 - Drug Product
 Listing (New
 drug listings)
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(4) Form FDA-2658                146              10.06              1,469               2.50           3,672.50
 - Registered
 Establishments'
 Report of
 Private Label
 Distributors
 (New listings
 for private
 label
 distributor
 drugs)
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(5) Form FDA-2657              1,677              11.21             18,797               2.50          46,992.50
 and Form FDA-
 2658 - (June and
 December updates
 of all listing
 information)
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Total              .................  .................  .................  .................            102,260
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[[Page 48658]]

    Dated: August 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16795 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S