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, 67733-67735 [E7-23275]
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67733
Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
EXHIBIT 1.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Data entry into GRS ........................................................................................
.
500
3
10/60
250
Total ..........................................................................................................
500
na
na
250
EXHIBIT 2.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total burden
hours
Average
hourly
wage rate*
Total cost
burden
Data entry into GRS ........................................................................................
.
500
250
$30.00
$7,500
Total ..........................................................................................................
500
250
na
7,500
*Based upon the average wages, ‘‘National Compensation Survey: Occupational Wages in the United States, May 2006,’’ U.S. Department of
Labor, Bureau of Labor Statistics.
This information collection will not
impose a cost burden on the
respondents beyond that associated
with their time to provide the required
data. There will be no additional costs
for capital equipment, software,
computer services, etc.
Dated: November 26, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–5886 Filed 11–29–07; 8:45 am]
Estimated Annual Costs to the Federal
Government
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The annual cost to the government is
$100,000 for licensing, support and
maintenance.
Food and Drug Administration
rwilkins on PROD1PC63 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
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BILLING CODE 4160–90–M
[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.
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0045. Also
include the FDA docket number found
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 current1 21 CFR 207.20,
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
E:\FR\FM\30NON1.SGM
Continued
30NON1
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Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
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 current §§ 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 drughandling activity must be submitted as
amendments to registration under
current § 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 § 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 § 207.31, a copy of all
advertisements and a quantitative listing
of all ingredients for each listed drug or
Number of
Respondents
Form
(1) Form FDA–2656—Registration of Drug Establishment (New registrations, including new labeler codes for private label distributors)
Number of Responses
Per Respondent
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 § 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:
Total Annual
Responses
Hours Per
Responses
Total Hours
14.72
574
2.50
1,435
(2) Form FDA–2656—Annual Update of Drug Establishment (Update of registration information)
3,256
2.99
9,763
2.50
24,407.50
(3) Form FDA–2657—Drug Product Listing (New
drug listings)
rwilkins on PROD1PC63 with NOTICES
39
1,567
6.57
10,301
2.50
25,752.50
146
10.06
1,469
2.50
3,672.50
(4) Form FDA–2658—Registered Establishments’
Report of Private Label Distributors (New listings
for private label distributor drugs)
information collection for revised part 207 will
replace the information collection in this notice.
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67735
Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
Number of
Respondents
Form
(5) Form FDA–2657 and Form FDA–2658—(June
and December updates of all listing information)
Number of Responses
Per Respondent
1,677
11.21
Total Annual
Responses
Hours Per
Responses
18,797
2.50
Total
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0277]
Food Labeling: Use of Symbols to
Communicate Nutrition Information,
Consideration of Consumer Studies
and Nutritional Criteria; Reopening of
Comment Period
Food and Drug Administration,
HHS.
Notice of public hearing;
reopening of comment period.
ACTION:
rwilkins on PROD1PC63 with NOTICES
46,992.50
102,260
Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23275 Filed 11–29–07; 8:45 am]
AGENCY:
Total Hours
SUMMARY: The Food and Drug
Administration (FDA) is reopening to
January 15, 2008, the comment period
for the notice of public hearing that
published in the Federal Register of
July 20, 2007. In the notice of public
hearing, FDA requested comments on
the use of symbols to communicate
nutrition information on food labels.
The agency is taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments.
DATES: Submit written or electronic
comments by January 15, 2008.
ADDRESSES: You may submit comments,
identified by Docket No. 2007N–0277,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD-ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
VerDate Aug<31>2005
16:27 Nov 29, 2007
Jkt 214001
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described
previously in the ADDRESSES portion of
this document under Electronic
Submissions .
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Juanita Yates, Center for Food Safety
and Applied Nutrition (HFS–555), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1731.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 20,
2007 (72 FR 39815), FDA published a
notice of public hearing with a 115-day
comment period to request comments
on the use of symbols to communicate
nutrition information on food labels,
specifically, the issues and questions
presented in section III of the notice (see
72 FR 39815 at 39816). Comments will
inform FDA’s consideration of the use of
symbols to communicate nutrition
information on food labels.
The agency has received a request for
a 60-day extension of the comment
period for the notice of public hearing.
The request conveyed concern that the
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
comment period, which closed 60 days
subsequent to the public hearing held
September 10 and 11, 2007, did not
allow sufficient time to develop a
meaningful or thoughtful response to
the request for comments on the issues
and questions presented in section III of
the notice.
FDA has considered the request and
is reopening the comment period for the
notice of public hearing, which closed
November 12, 2007, for 60 days, until
January 15, 2008. The agency believes
that reopening the comment period for
60 days allows adequate time for
interested persons to submit comments
on the issues and questions presented in
section III of the notice without
significantly delaying the agency’s
consideration of the use of symbols to
communicate nutrition information on
food labels.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23211 Filed 11–29–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67733-67735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23275]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 baguilar@omb.eop.gov. 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
Number of Number of Responses Total Annual Hours Per
Form Respondents Per Respondent Responses Responses Total Hours
----------------------------------------------------------------------------------------------------------------
(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)
----------------------------------------------------------------------------------------------------------------
(2) Form FDA-2656--Annual 3,256 2.99 9,763 2.50 24,407.50
Update of Drug
Establishment (Update of
registration information)
----------------------------------------------------------------------------------------------------------------
(3) Form FDA-2657--Drug 1,567 6.57 10,301 2.50 25,752.50
Product Listing (New drug
listings)
----------------------------------------------------------------------------------------------------------------
(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)
----------------------------------------------------------------------------------------------------------------
[[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)
----------------------------------------------------------------------------------------------------------------
Total 102,260
----------------------------------------------------------------------------------------------------------------
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
