[Federal Register Volume 66, Number 28 (Friday, February 9, 2001)]
[Notices]
[Pages 9709-9710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1567]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
March 12, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug 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 No. 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 Secs. 207.21 and 207.22, establishments 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). 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 
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.

[[Page 9710]]

    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 Annual Reporting Burden \1\
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                                                                                              No. of          Annual
                                Reporting                                     No. of       Respones per   Frequency  per   Total Annual      Hours per
                                                                            Respondents     Respondent       Response        Responses       Response
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(1) Form FDA-2656 Registration of Drug Establishment                       15,802                .34        5,438                .5         2,719
21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40
(2) Form FDA-2656e Annual Update of Drug Establishment                      7,226               1           7,226                .5         3,613
21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40
(3) Form FDA-2657 Drug Product Listing                                     14,381               2.80       40,270                .5        20,135
21 CFR 207.21, 207.22, 207.25, 207.30, 207.31, and 207.40
(4) Form FDA-2658 Registered Establishments' Report of Private Label        6,221               2.14       13,289                .5         6,645
 Distributors
21 CFR 207.21, 207.22, 207.25, 207.30, and 207.31
Total Reporting Burden                                                                                                                    33,112
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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 November 2, 2000 (65 FR 65858), the 
agency requested comments on the proposed collections of information. 
The agency received one comment on the 60-day notice. The comment 
recommended that FDA eliminate the requirement to send a representative 
label and/or carton with each Form FDA 2657 and 2658, and that, 
instead, the labeling would be available and submitted to FDA upon 
request.
    FDA appreciates the recommendation concerning labeling submissions. 
However, the comment is beyond the scope of the November 2, 2000, 
notice. That notice provided an opportunity for public comment on the 
agency's estimates of the burden resulting from the information 
collection requirements imposed by part 207. In the Federal Register of 
November 30, 2000 (65 FR 73798), FDA announced as part of the 
semiannual regulatory agenda that it intends to publish a proposed rule 
to revise part 207 to clarify the requirements for registration and 
listing and to consolidate and reorganize the regulations. The proposal 
would also require the electronic submission of establishment 
registration and product listing information. It would be more 
appropriate to submit the comment to that proposed rule after it 
publishes in the Federal Register.

    Dated: February 5, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3414 Filed 2-8-01; 8:45 am]
BILLING CODE 4160-01-F