[Federal Register Volume 65, Number 213 (Thursday, November 2, 2000)]
[Notices]
[Pages 65858-65859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28135]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1567]


Agency Information Collection Activities; Proposed Collection; 
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 January 2, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Information 
Resources Management (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: (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 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.
    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

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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      No. of Responses   Total Annual      Hours per
      Form       21 CFR  Section    Respondents     per Respondent     Responses       Response      Total Hours
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Form FDA 2656--          207.21    15,802                 .34         5,438               0.5        2,719
 Registration            207.22
 of Drug                 207.25
 Establishment           207.26
                         207.40
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Form FDA 2656e--         207.21     7,226                1            7,226               0.5        3,613
 Annual Update           207.22
 of Drug                 207.25
 Establishment           207.26
                         207.40
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Form FDA 2657--          207.21    14,381                2.80        40,270               0.5       20,135
 Drug Product            207.22
 Listing                 207.25
                         207.30
                         207.31
                         207.40
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Form FDA 2658--          207.21     6,221                2.14        13,289               0.5        6,645
 Registered              207.22
 Establishments          207.25
 ' Report of             207.30
 Private Label           207.31
 Distributors
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Total                                                                                               33,112
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 25, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-28135 Filed 11-01-00; 8:45 am]
BILLING CODE 4160-01-F