Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 59704-59705 [2011-24788]
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59704
Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices
telephone 770–488–8806, MWilliamsJohnson@cdc.gov
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
On March
23, 2010, the President signed into law
the Affordable Care Act (ACA), Public
Law 111–148. ACA is designed to
improve and expand the scope of health
care coverage for Americans. Cost
savings through disease prevention is an
important element of this legislation
and ACA has established a Prevention
and Public Health Fund (PPHF) for this
purpose. Specifically, the legislation
states in Section 4002 that the PPHF is
to ‘‘provide for expanded and sustained
national investment in prevention and
public health programs to improve
health and help restrain the rate of
growth in private and public sector
health care costs.’’ ACA and the
Prevention and Public Health Fund
make improving public health a priority
with investments to improve public
health.
The PPHF states that the Secretary
shall transfer amounts in the Fund to
accounts within the Department of
Health and Human Services to increase
funding, over the fiscal year 2008 level,
for programs authorized by the Public
Health Service Act, for prevention,
wellness and public health activities
including prevention research and
health screenings, such as the
Community Transformation Grant
Program, the Education and Outreach
Campaign for Preventative Benefits, and
Immunization Programs.
Therefore, increasing funding
available to applicants under this FOA
using the PPHF will allow them to
sustain their existing to provide for a
national investment in prevention and
public health programs. Further, The
Secretary allocated funds to CDC,
pursuant to the PPHF, for the types of
activities this FOA is designed to carry
out.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: September 16, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–24747 Filed 9–26–11; 8:45 am]
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[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reprocessed single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by November 28, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the 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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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
SUMMARY:
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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
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.
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. Section 301 of the
Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250) amended section 502 of the FD&C
Act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Thus, the name for this information
collection activity has been changed to
more accurately describe the
information collection content.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005 (Pub.
L. 109–43) amends section 502(u) of the
FD&C Act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Under the amended provision, if
the original SUD or an attachment to it
prominently and conspicuously bears
the name of the manufacturer, then the
reprocessor of the SUD is required to
identify itself by name, abbreviation, or
symbol, in a prominent and
conspicuous manner on the device or
attachment to the device. If the original
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Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices
SUD does not prominently and
conspicuously bear the name of the
manufacturer, the manufacturer who
reprocesses the SUD for reuse may
identify itself using a detachable label
that is intended to be affixed to the
patient record.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
FD&C Act Section
502(u) ...................................................................................
1. There
Dated: September 22, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–24788 Filed 9–26–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0108]
Guidance for Industry on User Fee
Waivers, Reductions, and Refunds for
Drug and Biological Products;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘User Fee Waivers, Reductions,
and Refunds for Drug and Biological
Products.’’ This guidance provides
recommendations to applicants
considering whether to request a waiver
or reduction in user fees. This guidance
is a revision of the draft guidance
entitled ‘‘Draft Interim Guidance
Document for Waivers of and
Reductions in User Fees,’’ issued July
16, 1993.
SUMMARY:
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10
Total annual
responses
100
1,000
Average
burden per
response
Total hours
0.1
100
are no capital costs or operating and maintenance costs associated with this collection of information.
The requirements of section 502(u) of
the FD&C Act impose a minimal burden
on industry. This section of the FD&C
Act only requires the manufacturer,
packer, or distributor of a device to
include their name and address on the
labeling of a device. This information is
readily available to the establishment
and easily supplied. From its
registration and premarket submission
database, FDA estimates that there are
10 establishments that distribute
approximately 1,000 reprocessed SUDs.
Each response is anticipated to take 0.1
hours resulting in a total burden to
industry of 100 hours.
AGENCY:
No. of
responses per
respondent
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Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the 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; or the
Office of Communication, Outreach, and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on this
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:
Michael Jones, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6216,
Silver Spring, MD 20993–0002, 301–
796–3602; or
Stephen Ripley, Center for Biologics
Evaluation and Research, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘User
Fee Waivers, Reductions, and Refunds
for Drug and Biological Products.’’ This
guidance provides recommendations for
applicants planning to request waivers
or reductions in user fees assessed
under sections 735 and 736 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379g and
379h, respectively). This guidance
describes the types of waivers and
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reductions permitted under the user fee
provisions of the FD&C Act and the
procedures for submitting requests for
waivers or reductions and requests for
reconsideration and appeal. The
guidance also provides clarification on
related issues such as user fee
exemptions for orphan drugs.
In the Federal Register of March 14,
2011 (76 FR 13629), FDA announced the
availability of a revised draft guidance
entitled ‘‘User Fee Waivers, Reductions,
and Refunds for Drug and Biological
Products.’’ The notice gave interested
persons the opportunity to comment by
June 13, 2011. We received no
comments on the revised draft guidance;
however, we have made minor editorial
changes and a small clarification to the
guidance document.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on user fee waivers and
reductions for drug products. 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. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance were approved under
OMB control number 0910–0639. The
guidance also refers to collections of
information for filling out and
submitting Form FDA 3397
(Prescription Drug User Fee Coversheet),
previously approved under OMB
control number 0910–0297, and
collections of information associated
with new drug applications or biologics
license applications approved under
OMB control numbers 0910–0001 and
0910–0338, respectively.
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[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59704-59705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0672]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices
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 reprocessed single-use device
labeling.
DATES: Submit either electronic or written comments on the collection
of information by November 28, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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 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.
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
(OMB Control Number 0910-0577)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 352), among other things, establishes requirements that the
label or labeling of a medical device must meet so that it is not
misbranded and subject to regulatory action. Section 301 of the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended
section 502 of the FD&C Act to add section 502(u) to require devices
(both new and reprocessed) to bear prominently and conspicuously the
name of the manufacturer, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying the
manufacturer. Thus, the name for this information collection activity
has been changed to more accurately describe the information collection
content.
Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (Pub. L. 109-43) amends section 502(u) of the FD&C Act by limiting
the provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended provision, if the
original SUD or an attachment to it prominently and conspicuously bears
the name of the manufacturer, then the reprocessor of the SUD is
required to identify itself by name, abbreviation, or symbol, in a
prominent and conspicuous manner on the device or attachment to the
device. If the original
[[Page 59705]]
SUD does not prominently and conspicuously bear the name of the
manufacturer, the manufacturer who reprocesses the SUD for reuse may
identify itself using a detachable label that is intended to be affixed
to the patient record.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Average
FD&C Act Section No. of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
502(u).......................... 10 100 1,000 0.1 100
----------------------------------------------------------------------------------------------------------------
\1.\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The requirements of section 502(u) of the FD&C Act impose a minimal
burden on industry. This section of the FD&C Act only requires the
manufacturer, packer, or distributor of a device to include their name
and address on the labeling of a device. This information is readily
available to the establishment and easily supplied. From its
registration and premarket submission database, FDA estimates that
there are 10 establishments that distribute approximately 1,000
reprocessed SUDs. Each response is anticipated to take 0.1 hours
resulting in a total burden to industry of 100 hours.
Dated: September 22, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-24788 Filed 9-26-11; 8:45 am]
BILLING CODE 4160-01-P
