Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements, 14471-14472 [E8-5384]
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Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Notices
Dated: March 12, 2008.
Diane Allen,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E8–5376 Filed 3–17–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0162]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Product Labeling: Medication Guide
Requirements
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
ACTION:
[Docket No. FDA–2008–N–0157 (formerly
2007N–0105)]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Mental Models Study of Food
Terrorism Risk Awareness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Mental Models Study of Food
Terrorism Risk Awareness’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of July 24, 2007 (72 FR
40309), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0618. The
approval expires on February 28, 2011.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
mstockstill on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: March 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–5361 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S
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17:39 Mar 17, 2008
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Food and Drug Administration,
HHS.
Notice.
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
regulations requiring the distribution of
patient labeling, called Medications
Guides, for certain products that pose a
serious and significant public health
concern requiring distribution of FDAapproved patient medication.
DATES: Submit written or electronic
comments on the collection of
information by May 19, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to Division of Dockets
Management (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:
Elizabeth Berbakos, Office of the Chief
Information Officer (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
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14471
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 these topics: (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
assumption 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.
Prescription Drug Product Labeling:
Medication Guide Requirements (OMB
Control Number 0910–0393)—Extension
FDA regulations require the
distribution of patient labeling, called
Medication Guides, for certain
prescription human drug and biological
products used primarily on an
outpatient basis that pose a serious and
significant public health concern
requiring distribution of FDA-approved
patient medication information. These
Medication Guides inform patients
about the most important information
they should know about these products
in order to use them safely and
effectively. Included is information such
as the drug’s approved uses,
contraindications, adverse drug
reactions, and cautions for specific
populations, with a focus on why the
particular product requires a Medication
Guide. These regulations are intended to
improve the public health by providing
information necessary for patients to use
certain medications safely and
effectively.
The regulations contain the following
reporting requirements that are subject
to the PRA. The estimates for the burden
hours imposed by the following
regulations are listed in table 1 of this
document:
• 21 CFR 208.20—Applicants must
submit draft Medication Guides for FDA
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14472
Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Notices
approval according to the prescribed
content and format.
• 21 CFR 208.24(e)—Each authorized
dispenser of a prescription drug product
for which a Medication Guide is
required, when dispensing the product
to a patient or to a patient’s agent, must
provide a Medication Guide directly to
each patient unless an exemption
applies under § 208.26 (21 CFR 208.26).
• Section 208.26(a)—Requests may be
submitted for exemption or deferral
from particular Medication Guide
content or format requirements.
• 21 CFR 314.70(b)(3)(ii) and 21 CFR
601.12(f)—Application holders must
submit changes to Medication Guides to
FDA for prior approval as supplements
to their applications.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
208.20
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
10
1
10
320
3,200
208.24(e)
59,000
5,000
295 million
.0014
413,000
208.26(a)
1
1
1
4
4
314.70(b)(3)(ii) and 601.12(f)
5
1
5
72
360
Total
416,564
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–5384 Filed 3–17–08; 8:45 am]
In FR Doc.
E8–316, published on January 11, 2008
(73 FR 2055), the following correction is
made:
On page 2055, in the second column,
in the SUMMARY and SUPPLEMENTARY
INFORMATION sections, ‘‘Oyi’’ is corrected
to read ‘‘Oyj’’.
SUPPLEMENTARY INFORMATION:
Dated: March 7, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–5453 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Food and Drug Administration
[Docket No. 2007F–0478]
Kemira Oyj; Filing of Food Additive
Petition (Animal Use); Partially
Ammoniated Formic Acid; Correction
AGENCY:
Food and Drug Administration,
mstockstill on PROD1PC66 with NOTICES
Health Resources and Services
Administration, HHS.
AGENCY:
Notice of Meeting of the
Advisory Committee on Organ
Transplantation.
ACTION:
HHS.
ACTION:
Meeting of the Advisory Committee on
Organ Transplantation
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
document announcing the filing of a
food additive petition that appeared in
the Federal Register of January 11,
2008. FDA is correcting the name of the
petitioner which was misspelled during
document drafting.
DATES: This correction is effective
March 18, 2008.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–267–9019, email: george.haibel@fda.hhs.gov.
VerDate Aug<31>2005
17:39 Mar 17, 2008
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SUMMARY: Pursuant to Public Law 92–
463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2),
notice is hereby given of the fourteenth
meeting of the Advisory Committee on
Organ Transplantation (ACOT),
Department of Health and Human
Services (HHS). The meeting will be
held from approximately 9 a.m. to 5:30
p.m. on May 5, 2008, and from 9 a.m.
to 3 p.m. on May 6, 2008, at the Hilton
Washington D.C./Rockville Executive
Meeting Center, 1750 Rockville Pike,
Rockville, MD 20852. The meeting will
be open to the public; however, seating
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is limited and pre-registration is
encouraged (see below).
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. Section 217a,
Section 222 of the Public Health Service
Act, as amended, and 42 CFR 121.12
(2000), ACOT was established to assist
the Secretary in enhancing organ
donation, ensuring that the system of
organ transplantation is grounded in the
best available medical science, and
assuring the public that the system is as
effective and equitable as possible, and,
thereby, increasing public confidence in
the integrity and effectiveness of the
transplantation system. ACOT is
composed of up to 25 members,
including the Chair. Members are
serving as Special Government
Employees and have diverse
backgrounds in fields such as organ
donation, health care public policy,
transplantation medicine and surgery,
critical care medicine and other medical
specialties involved in the identification
and referral of donors, non-physician
transplant professions, nursing,
epidemiology, immunology, law and
bioethics, behavioral sciences,
economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members.
ACOT will hear presentations on the
‘‘Kidney Disease Outcome Quality
Initiative/Early Kidney Transplantation
Conference’’ held on March 19–20,
2007; adolescent/medication
nonadherence/transitioning from
pediatric-adolescent care to adult care;
revised informed consent
recommendation; recovery/allocation/
transplantation practices outside the
United States; and a final report on the
economics of transplantation. The four
ACOT work groups also will update the
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]]>Agencies
[Federal Register Volume 73, Number 53 (Tuesday, March 18, 2008)]
[Notices]
[Pages 14471-14472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5384]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0162]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Product Labeling: Medication Guide
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 regulations requiring the
distribution of patient labeling, called Medications Guides, for
certain products that pose a serious and significant public health
concern requiring distribution of FDA-approved patient medication.
DATES: Submit written or electronic comments on the collection of
information by May 19, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to Division of Dockets Management (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: Elizabeth Berbakos, Office of the
Chief Information Officer (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 these topics: (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 assumption 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.
Prescription Drug Product Labeling: Medication Guide Requirements (OMB
Control Number 0910-0393)--Extension
FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern requiring distribution of
FDA-approved patient medication information. These Medication Guides
inform patients about the most important information they should know
about these products in order to use them safely and effectively.
Included is information such as the drug's approved uses,
contraindications, adverse drug reactions, and cautions for specific
populations, with a focus on why the particular product requires a
Medication Guide. These regulations are intended to improve the public
health by providing information necessary for patients to use certain
medications safely and effectively.
The regulations contain the following reporting requirements that
are subject to the PRA. The estimates for the burden hours imposed by
the following regulations are listed in table 1 of this document:
21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA
[[Page 14472]]
approval according to the prescribed content and format.
21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required,
when dispensing the product to a patient or to a patient's agent, must
provide a Medication Guide directly to each patient unless an exemption
applies under Sec. 208.26 (21 CFR 208.26).
Section 208.26(a)--Requests may be submitted for exemption
or deferral from particular Medication Guide content or format
requirements.
21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides to FDA for prior
approval as supplements to their applications.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.20 10 1 10 320 3,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.24(e) 59,000 5,000 295 million .0014 413,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.26(a) 1 1 1 4 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.70(b)(3)(ii) and 601.12(f) 5 1 5 72 360
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 416,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5384 Filed 3-17-08; 8:45 am]
BILLING CODE 4160-01-S
