[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67733-67735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0323]


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 
December 31, 2007.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0045. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

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.

Comment Request; Registration of Producers of Drugs and Listing of 
Drugs in Commercial Distribution--(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,

[[Page 67734]]

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 August 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 the table in 
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 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.
    In the Federal Register of August 24, 2007 (72 FR 48656), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the annual information collection burden for current 
part 207 as follows:

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                               Number of     Number of Responses   Total Annual      Hours Per
           Form               Respondents      Per Respondent        Responses       Responses      Total Hours
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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--Annual            3,256                  2.99           9,763            2.50       24,407.50
 Update of Drug
 Establishment (Update of
 registration information)
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(3) Form FDA-2657--Drug              1,567                  6.57          10,301            2.50       25,752.50
 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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[[Page 67735]]

 
(5) Form FDA-2657 and Form           1,677                 11.21          18,797            2.50       46,992.50
 FDA-2658--(June and
 December updates of all
 listing information)
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Total                                                                                                    102,260
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    Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23275 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-01-S