Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 43841-43842 [2012-18233]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
administrative aspects of acquisitionsupported activities to assure
compliance with appropriate DHHS and
CDC policies and application to public
health activities; (4) gives technical
assistance, where indicated, to improve
the management of acquisition
activities, and responds to requests for
management information from the
Office of the Director, headquarters,
regional staffs, CDC program offices and
the public; (5) performs contract and
purchasing administrative activities
including coordination and negotiation
of contract modifications, reviewing and
approving contractor billings, resolving
audit findings, and performing closeout/termination activities; (6) provides
for the collection and reporting of
business management and public health
programmatic data, and analyzes and
monitors business management data on
grants and cooperative agreements; (7)
assures that contractor performance is in
accordance with contractual
commitments; (8) provides leadership
and guidance to CDC project officers
and program officials; (9) provides
leadership, direction, procurement
options, and approaches in developing
specifications/statements of work and
contract awards; (10) participates with
top program management in public
health program planning, policy
determination, evaluation, and
directions concerning acquisition
strategies and execution; (11) maintains
branch’s official contract files; (12)
maintains a close working relationship
with CDC program office components in
carrying out their missions; and (13)
establishes branch goals, objectives, and
priorities, and assures their consistency
and coordination with the overall
objectives of PGO and CDC.
Logistics Management Branch
(CAJHW). (1) Develops and implements
CDC-wide policies, procedures, and
criteria necessary to comply with
federal and departmental regulations
governing personal property,
transportation, shipping, and fleet
management; (2) determines,
recommends, and implements
procedural changes needed to maintain
effective management of CDC property
including but not limited to: Inventory
control; property records; receipt,
delivery, tracking, shipping and return
of CDC materiel; property reutilization
and disposal; transportation of freight;
and CDC’s vehicle fleet; (3) provides
audits, training and technical assistance
to CDC Centers/Institute/Offices on
property, transportation, shipping, and
fleet management; (4) determines the
requirement for and serves as the
functional proponent for the design,
VerDate Mar<15>2010
16:42 Jul 25, 2012
Jkt 226001
test, and implementation of logistics
management systems; (5) represents
CDC on inter-and intra-departmental
committees relevant to logistical
functions; (6) serves as the CDC liaison
to HHS and other federal agencies on
logistical matters such as property,
transportation and traffic management;
and (7) establishes branch goals,
objectives and priorities, and assures
consistency and coordination with
overall Procurement and Grants Office
logistical goals and objectives.
Dated: July 3, 2012.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2012–17990 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0454]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Questions and Answers
Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 August 27,
2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0640. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
43841
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–7651, juanmanuel.vilela@
fda.hhs.gov.
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.
Guidance for Industry on Questions
and Answers Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act—(OMB
Control Number 0910–0640)—Extension
On December 22, 2006, the President
signed into law the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act (Pub. L. 109–462, 120
Stat. 3469). This law amends the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) with respect to serious
adverse event reporting for dietary
supplements and nonprescription drugs
marketed without an approved
application.
Section 502(x) of the FD&C Act (21
U.S.C. 352(x)), which was added by
Public Law 109–462, requires the label
of a nonprescription drug product
marketed without an approved
application in the United States to
include a domestic address or domestic
telephone number through which a
responsible person may receive a report
of a serious adverse event associated
with the product. The guidance
document contains questions and
answers relating to this labeling
requirement and provides guidance to
industry on the following topics: (1) The
meaning of ‘‘domestic address’’ for
purposes of the labeling requirements of
section 502(x) of the FD&C Act; (2)
FDA’s recommendation for the use of an
introductory statement before the
domestic address or phone number that
is required to appear on the product
label under section 502(x) of the FD&C
Act; and (3) FDA’s intent regarding
enforcing the labeling requirements of
section 502(x) of the FD&C Act. Separate
guidance, issued by the Center for Food
Safety and Applied Nutrition on
reporting for dietary supplements, is
announced elsewhere in the Federal
Register.
Title: Guidance for Industry on
Questions and Answers Regarding the
Labeling of Nonprescription Human
Drug Products Marketed Without an
Approved Application as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act.
E:\FR\FM\26JYN1.SGM
26JYN1
43842
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) of the FD&C Act)
appears on the label of a
nonprescription drug product marketed
in the United States without an
approved application.
Burden Estimate: FDA is requesting
public comment on the estimated onetime reporting burden from these
respondents, as required by 502(x) of
the FD&C Act and described in the
guidance ‘‘Questions and Answers
Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.’’ The
estimates for one-time reporting are
based on FDA’s knowledge of
nonprescription drug product labeling
in the United States, whether or not
marketed under an approved
application.
In the Federal Register of May 15,
2012 (77 FR 28604), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Number of
responses
per
respondent
Total
responses
Average
burden per
response
Total hours
200
500
100,000
4
400,000
Domestic address or phone number labeling requirement
(21 U.S.C. 502(x)) and recommendation to clarify its
purpose .............................................................................
1 There
are no capital costs or maintenance and operating costs associated with this collection of information.
TKELLEY on DSK3SPTVN1PROD with NOTICES
As indicated in table 1 of this
document, FDA estimates that
approximately 200 manufacturers will
revise approximately 100,000 labels to
add a full domestic address and a
domestic telephone number, and should
they choose to adopt the guidance’s
recommendation, to add a statement
identifying the purpose of the domestic
address or telephone number. FDA
believes that designing the label change
should not take longer than 4 hours per
label. Automated printing of the labels
should only require a few seconds per
label. This estimate accounts for the
possibility that every manufacturer will
make label revision, which is unlikely.
Because the majority of over-the-counter
drug product labels currently have a
domestic telephone number that
satisfies the requirement, we believe
many manufacturers will opt not to
adopt the guidance’s recommendation
to add a statement identifying the
purpose of the address or telephone
number, significantly reducing the
number of total responses. However,
assuming that all labels are revised, we
estimate a one-time reporting burden for
this information collection of 400,000
hours.
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18233 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0473]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Irradiation in the Production,
Processing, and Handling of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 August 27,
2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0186. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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16:42 Jul 25, 2012
Jkt 226001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
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:
Irradiation in the Production,
Processing, and Handling of Food—21
CFR Part 179 (OMB Control Number
0910–0186)—Extension
Under sections 201(s) and 409 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 321(s) and
348), food irradiation is subject to
regulation under the food additive
premarket approval provisions of the
FD&C Act. The regulations providing for
uses of irradiation in the production,
processing, and handling of food are
found in part 179 (21 CFR part 179). To
ensure safe use of a radiation source,
§ 179.21(b)(1) requires that the label of
sources bear appropriate and accurate
information identifying the source of
radiation and the maximum (or
minimum and maximum) energy of
radiation emitted by X-ray tube sources.
Section 179.21(b)(2) requires that the
label or accompanying labeling bear
adequate directions for installation and
use and a statement supplied by FDA
that indicates maximum dose of
radiation allowed. Section 179.26(c)
requires that the label or accompanying
labeling bear a logo and a radiation
disclosure statement. Section 179.25(e)
requires that food processors who treat
food with radiation make and retain, for
1 year past the expected shelf life of the
products up to a maximum of 3 years,
specified records relating to the
E:\FR\FM\26JYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43841-43842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0454]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Questions and Answers Regarding the Labeling of Nonprescription
Human Drug Products Marketed Without an Approved Application as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act
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 August
27, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0640.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651, juanmanuel.vilela@fda.hhs.gov.
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.
Guidance for Industry on Questions and Answers Regarding the Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act--(OMB Control Number 0910-0640)--Extension
On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L.
109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application.
Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added
by Public Law 109-462, requires the label of a nonprescription drug
product marketed without an approved application in the United States
to include a domestic address or domestic telephone number through
which a responsible person may receive a report of a serious adverse
event associated with the product. The guidance document contains
questions and answers relating to this labeling requirement and
provides guidance to industry on the following topics: (1) The meaning
of ``domestic address'' for purposes of the labeling requirements of
section 502(x) of the FD&C Act; (2) FDA's recommendation for the use of
an introductory statement before the domestic address or phone number
that is required to appear on the product label under section 502(x) of
the FD&C Act; and (3) FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the FD&C Act. Separate guidance,
issued by the Center for Food Safety and Applied Nutrition on reporting
for dietary supplements, is announced elsewhere in the Federal
Register.
Title: Guidance for Industry on Questions and Answers Regarding the
Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.
[[Page 43842]]
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(under section 502(b)(1) of the FD&C Act) appears on the label of a
nonprescription drug product marketed in the United States without an
approved application.
Burden Estimate: FDA is requesting public comment on the estimated
one-time reporting burden from these respondents, as required by 502(x)
of the FD&C Act and described in the guidance ``Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act.'' The estimates for
one-time reporting are based on FDA's knowledge of nonprescription drug
product labeling in the United States, whether or not marketed under an
approved application.
In the Federal Register of May 15, 2012 (77 FR 28604), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total responses Average burden Total hours
respondents respondent per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic address or phone number labeling requirement (21 U.S.C. 200 500 100,000 4 400,000
502(x)) and recommendation to clarify its purpose.................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance and operating costs associated with this collection of information.
As indicated in table 1 of this document, FDA estimates that
approximately 200 manufacturers will revise approximately 100,000
labels to add a full domestic address and a domestic telephone number,
and should they choose to adopt the guidance's recommendation, to add a
statement identifying the purpose of the domestic address or telephone
number. FDA believes that designing the label change should not take
longer than 4 hours per label. Automated printing of the labels should
only require a few seconds per label. This estimate accounts for the
possibility that every manufacturer will make label revision, which is
unlikely. Because the majority of over-the-counter drug product labels
currently have a domestic telephone number that satisfies the
requirement, we believe many manufacturers will opt not to adopt the
guidance's recommendation to add a statement identifying the purpose of
the address or telephone number, significantly reducing the number of
total responses. However, assuming that all labels are revised, we
estimate a one-time reporting burden for this information collection of
400,000 hours.
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18233 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P
