Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Availability, 39710-39711 [2012-16244]
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39710
Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
7. The U.S. Repatriation Program
Temporary Assistance Extension
Request Form: Under 45 CFR parts 211
& 212 temporary assistance may be
furnished beyond the 90 days eligibility
period if the individual falls within the
eligibility requirements for an
extension. This form is to be completed
by the eligible repatriates or authorized
legal custodian or state repatriation
coordinator whenever appropriate. This
form must be submitted to ORR or its
authorized grantee 14 days prior to the
90 days eligibility period ends, unless
the circumstances surrounding the case
merits submission after the 14th day.
8. The U.S. Repatriation Program
Individual Case Management Report
and Financial Claim Form: Under
Section 1113 of the Social Security Act,
ORR is authorized to provide temporary
assistance directly or through utilization
of the services and facilities of
appropriate public or private agencies
and organizations, in accordance with
agreements providing for payment, in
advance or by way of reimbursement, as
may be determined by ORR. This form
is to be utilized and completed by ORR
partners to request reimbursement of
reasonable and allowable costs, both
administrative and actual temporary
services, and to provide individual case
updates. This form is to be completed
by the eligible individual case worker
and/or service provider.
Respondents: Repatriation Program
partners (e.g. States, federal agencies,
non-governmental agencies, etc.) and
individuals repatriated or evacuated by
DOS from overseas. These respondents
are authorized under Title XI, Section
1113 of the Social Security Act (42
U.S.C. 1313), Executive Order 12656
(amended by E.O. 13074, February 9,
1998; E.O. 13228, October 8, 2001; E.O.
13286, February 28, 2003), and 45 CFR
parts 211 & 212.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Average
burden hours
per response
Number of
respondents
The U.S. Repatriation Program Emergency and
Group Processing Form.
The U.S. Repatriation Program Privacy and Repayment Agreement Form:
Relinquish Repatriation Services Form .......................
The U.S. Repatriation Program Emergency Reimbursement Form:
The U.S. Repatriation Program Non-emergency Reimbursement Form:
The U.S. Repatriation Program Financial Waiver Request Form:
The U.S. Repatriation Program Temporary Assistance Extension Request Form.
The U.S. Repatriation Program Individual Case Management Report and Financial Claim Form:
TKELLEY on DSK3SPTVN1PROD with NOTICES
Instrument
50 or more .......................
1
0.15
7.5 or more.
700 or more .....................
1
0.10
70 or more.
10 or more .......................
4 or more .........................
1
1
0.05
1
0.5 or more.
4 or more.
53 or more .......................
1
0.30
17.9 or more.
100 or more .....................
1
1
100 or more.
20 or more .......................
1
.30
53 or more .......................
1
1
Estimated Total Annual Burden
Hours: 258.90
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
VerDate Mar<15>2010
17:51 Jul 03, 2012
Jkt 226001
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Fmt 4703
Food and Drug Administration
[Docket No. FDA–2012–D–0529]
Draft Guidance for Industry on OrganSpecific Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Labeling for Products That
Contain Acetaminophen; Availability
Food and Drug Administration,
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Organ-Specific
Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Labeling for Products That
Contain Acetaminophen.’’ The draft
guidance is intended to inform
manufacturers of certain over-thecounter (OTC) internal analgesic,
antipyretic, and antirheumatic (IAAA)
drug products that contain
SUMMARY:
BILLING CODE 4184–01–P
Frm 00036
53 or more.
HHS.
[FR Doc. 2012–16285 Filed 7–3–12; 8:45 am]
PO 00000
6 or more.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Robert Sargis,
Reports Clearance Officer.
Total burden hours
Sfmt 4703
E:\FR\FM\05JYN1.SGM
05JYN1
Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
acetaminophen of the circumstances in
which FDA intends to exercise
enforcement discretion with regard to
the liver warning required in the
labeling.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 4,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tina
Walther, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5108, Silver Spring,
MD 20993–0002, 301–796–5086.
SUPPLEMENTARY INFORMATION:
DATES:
TKELLEY on DSK3SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Organ-Specific Warnings: Internal
Analgesic, Antipyretic, and
Antirheumatic Drug Products for Overthe-Counter Human Use—Labeling for
Products That Contain
Acetaminophen.’’ In the Federal
Register of December 26, 2006 (71 FR
77314), FDA published a proposed rule
on organ-specific warnings and related
labeling for OTC IAAA drug products.
In the Federal Register of April 29, 2009
(74 FR 19385), FDA published the final
rule (2009 final rule). In the Federal
Register of November 25, 2009 (74 FR
61512), FDA published a technical
amendment to clarify several provisions
in response to industry feedback. The
2009 final rule, as amended, changed
some of the labeling requirements for
OTC IAAA drug products to inform
consumers about the risk of liver injury
when using acetaminophen and the risk
of stomach bleeding when using
VerDate Mar<15>2010
16:48 Jul 03, 2012
Jkt 226001
nonsteroidal anti-inflammatory drugs. It
went into effect April 29, 2010.
The labeling for OTC IAAA products
that contain acetaminophen and are
labeled for adults only, must include the
following liver warning:
Liver warning: This product contains
acetaminophen. Severe liver damage may
occur if you take • more than [insert
maximum number of daily dosage units] in
24 hours, which is the maximum daily
amount [optional: ‘‘For this product’’] • with
other drugs containing acetaminophen • 3 or
more alcoholic drinks every day while using
this product.
Although the currently proposed total
daily dose of acetaminophen is 4,000
milligrams (mg), some OTC IAAA
products that contain acetaminophen
have directions for use that provide a
maximum daily dose of acetaminophen
for the product that is less than 4,000
mg. For example, for some OTC IAAA
drug products that contain both
acetaminophen and one or more other
active ingredients, the maximum
number of daily dosage units might be
limited by an active ingredient other
than acetaminophen, which could result
in a maximum daily dose of
acetaminophen that is less than 4,000
mg for that product. The optional
statement, ‘‘for this product,’’ in the first
bullet of the liver warning is intended
to address these situations, by clarifying
that the maximum number of daily
dosage units for a product might not
reflect the maximum daily dose of
acetaminophen.
However, the Agency understands
that in certain circumstances, despite
this optional statement, the wording of
the first bulleted warning might be
interpreted as indicating that severe
liver damage is associated with a total
daily dose of acetaminophen that is less
than 4,000 mg. This suggestion is not
the intent of the requirement that the
liver warning be included in the
labeling. To address this potential
confusion, the Agency intends to
exercise enforcement discretion with
respect to the liver warning required in
the circumstances described in this draft
guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
39711
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–16244 Filed 7–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c) (2) (A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
E:\FR\FM\05JYN1.SGM
05JYN1
]]>Agencies
[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39710-39711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16244]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0529]
Draft Guidance for Industry on Organ-Specific Warnings: Internal
Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-
Counter Human Use--Labeling for Products That Contain Acetaminophen;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Organ-Specific
Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human Use--Labeling for Products That
Contain Acetaminophen.'' The draft guidance is intended to inform
manufacturers of certain over-the-counter (OTC) internal analgesic,
antipyretic, and antirheumatic (IAAA) drug products that contain
[[Page 39711]]
acetaminophen of the circumstances in which FDA intends to exercise
enforcement discretion with regard to the liver warning required in the
labeling.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 4, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tina Walther, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5108, Silver Spring, MD 20993-0002, 301-
796-5086.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic,
and Antirheumatic Drug Products for Over-the-Counter Human Use--
Labeling for Products That Contain Acetaminophen.'' In the Federal
Register of December 26, 2006 (71 FR 77314), FDA published a proposed
rule on organ-specific warnings and related labeling for OTC IAAA drug
products. In the Federal Register of April 29, 2009 (74 FR 19385), FDA
published the final rule (2009 final rule). In the Federal Register of
November 25, 2009 (74 FR 61512), FDA published a technical amendment to
clarify several provisions in response to industry feedback. The 2009
final rule, as amended, changed some of the labeling requirements for
OTC IAAA drug products to inform consumers about the risk of liver
injury when using acetaminophen and the risk of stomach bleeding when
using nonsteroidal anti-inflammatory drugs. It went into effect April
29, 2010.
The labeling for OTC IAAA products that contain acetaminophen and
are labeled for adults only, must include the following liver warning:
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take more than [insert maximum
number of daily dosage units] in 24 hours, which is the maximum
daily amount [optional: ``For this product''] with other
drugs containing acetaminophen 3 or more alcoholic drinks
every day while using this product.
Although the currently proposed total daily dose of acetaminophen
is 4,000 milligrams (mg), some OTC IAAA products that contain
acetaminophen have directions for use that provide a maximum daily dose
of acetaminophen for the product that is less than 4,000 mg. For
example, for some OTC IAAA drug products that contain both
acetaminophen and one or more other active ingredients, the maximum
number of daily dosage units might be limited by an active ingredient
other than acetaminophen, which could result in a maximum daily dose of
acetaminophen that is less than 4,000 mg for that product. The optional
statement, ``for this product,'' in the first bullet of the liver
warning is intended to address these situations, by clarifying that the
maximum number of daily dosage units for a product might not reflect
the maximum daily dose of acetaminophen.
However, the Agency understands that in certain circumstances,
despite this optional statement, the wording of the first bulleted
warning might be interpreted as indicating that severe liver damage is
associated with a total daily dose of acetaminophen that is less than
4,000 mg. This suggestion is not the intent of the requirement that the
liver warning be included in the labeling. To address this potential
confusion, the Agency intends to exercise enforcement discretion with
respect to the liver warning required in the circumstances described in
this draft guidance.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16244 Filed 7-3-12; 8:45 am]
BILLING CODE 4160-01-P
