Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices, 21564-21565 [2012-8507]
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21564
Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices
Estimated Total Annual Burden
Hours: 1,333.20.
Additional Information
Copies of the proposed collection may
be obtained 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. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–8512 Filed 4–9–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0306]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Detention and Banned Medical 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
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SUMMARY:
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notice. This notice solicits comments on
information collection for
administrative detention and banned
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 11, 2012.
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,
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when appropriate, and other forms of
information technology.
Administrative Detention and Banned
Medical Devices—(OMB Control
Number 0910–0114)—Extension
FDA has the statutory authority under
section 304(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 334(g)) to detain during
established inspections devices that are
believed to be adulterated or
misbranded. Section 800.55 (21 CFR
800.55), on administrative detention,
includes among other things, certain
reporting requirements and
recordkeeping requirements. Under
§ 800.55(g), an applicant of a detention
order must show documentation of
ownership if devices are detained at a
place other than that of the appellant.
Under § 800.55(k), the owner or other
responsible person must supply records
about how the devices may have
become adulterated or misbranded, in
addition to records of distribution of the
detained devices. These recordkeeping
requirements for administrative
detentions permit FDA to trace devices
for which the detention period expired
before a seizure is accomplished or
injunctive relief is obtained.
FDA also has the statutory authority
under section 516 of the FD&C Act (21
U.S.C. 360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. Section 895.21 (21 CFR
895.21), on banned devices, contains
certain reporting requirements. Section
895.21(d) describes the procedures for
banning a device when the
Commissioner of Food and Drugs (the
Commissioner) decides to initiate such
a proceeding. Under 21 CFR 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
three firms whose devices had been
detained.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
800.55(g) ..........................................................
895.21(d) and 895.22(a) ..................................
Total ..........................................................
1
26
............................
1
1
............................
1
26
............................
25
16
............................
1 There
Total hours
25
416
441
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per
recordkeeping
Total hours
800.55(k) ..........................................................
1
1
1
20
20
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–8507 Filed 4–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0249. The
approval expires on March 31, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: April 3, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
Food and Drug Administration
[Docket No. FDA–2011–N–0439]
[FR Doc. 2012–8514 Filed 4–9–12; 8:45 am]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food and Drug Administration Recall
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Food and Drug Administration Recall
Regulations’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 28, 2011, the Agency
submitted a proposed collection of
information entitled ‘‘Food and Drug
Administration Recall Regulations’’ 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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 77 FR 13613–13616
dated March 7, 2012).
This notice reflects organizational
changes in the Health Resources and
Services Administration. Specifically,
this notice updates the functional
statement for the HIV/AIDS Bureau
(RV): (1) Rename the Division of Science
and Policy (RVA) to the Division of
Policy and Data (RVA) and update the
functional statement; (2) rename the
Office of Program Support (RV2) to the
Office of Operations and Management
(RV2); (3) rename the Division of
Service Systems (RV5) to the Division of
Metropolitan HIV/AIDS Programs (RV5)
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and update the function statement; (4)
establish the Division of State HIV/AIDS
Programs (RVD); (5) rename the Division
of Community Based Programs (RV6) to
the Division of Community HIV/AIDS
Programs (RV6); and rename the
Division of Training and Technical
Assistance (RV7) to the Division of HIV/
AIDS Training and Capacity
Development (RV7) and update the
functional statement.
Chapter RV—HIV/AIDS Bureau
Section RV–10, Organization
Delete in its entirety and replace with
the following:
The HIV/AIDS Bureau (RV) is headed
by the Associate Administrator, HIV/
AIDS Bureau (HAB), who reports
directly to the Administrator, Health
Resources and Services Administration.
HAB includes the following
components:
(1) Office of the Associate
Administrator (RV);
(2) Office of Operations and
Management (RV2);
(3) Division of Policy and Data (RVA);
(4) Division of Metropolitan HIV/
AIDS Programs (RV5);
(5) Division of State HIV/AIDS
Programs (RVD);
(6) Division of Community HIV/AIDS
Programs (RV6); and
(7) Division of HIV/AIDS Training
and Capacity Development (RV7).
Section RV–20, Functions
(1) Delete the functional statement for
the HIV/AIDS Bureau (RV) and replace
in its entirety.
Office of the Associate Administrator
(RV)
The Office of the Associate
Administrator provides leadership and
direction for the HIV/AIDS programs
and activities of the Bureau and
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]]>Agencies
[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21564-21565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0306]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Detention and Banned Medical 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 information collection for
administrative detention and banned medical devices.
DATES: Submit either electronic or written comments on the collection
of information by June 11, 2012.
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.
Administrative Detention and Banned Medical Devices--(OMB Control
Number 0910-0114)--Extension
FDA has the statutory authority under section 304(g) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to
detain during established inspections devices that are believed to be
adulterated or misbranded. Section 800.55 (21 CFR 800.55), on
administrative detention, includes among other things, certain
reporting requirements and recordkeeping requirements. Under Sec.
800.55(g), an applicant of a detention order must show documentation of
ownership if devices are detained at a place other than that of the
appellant. Under Sec. 800.55(k), the owner or other responsible person
must supply records about how the devices may have become adulterated
or misbranded, in addition to records of distribution of the detained
devices. These recordkeeping requirements for administrative detentions
permit FDA to trace devices for which the detention period expired
before a seizure is accomplished or injunctive relief is obtained.
FDA also has the statutory authority under section 516 of the FD&C
Act (21 U.S.C. 360f) to ban devices that present substantial deception
or an unreasonable and substantial risk of illness or injury. Section
895.21 (21 CFR 895.21), on banned devices, contains certain reporting
requirements. Section 895.21(d) describes the procedures for banning a
device when the Commissioner of Food and Drugs (the Commissioner)
decides to initiate such a proceeding. Under 21 CFR 895.22, a
manufacturer, distributor, or importer of a device may be required to
submit to FDA all relevant and available data and information to enable
the Commissioner to determine whether the device presents substantial
deception, unreasonable and substantial risk of illness or injury, or
unreasonable, direct, and substantial danger to the health of
individuals.
During the past several years, there has been an average of less
than one new administrative detention action per year. Each
administrative detention will have varying amounts of data and
information that must be maintained. FDA's estimate of the burden under
the administrative detention provision is based on FDA's discussion
with one of three firms whose devices had been detained.
FDA estimates the burden of this collection of information as
follows:
[[Page 21565]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(g)..................................................... 1 1 1 25 25
895.21(d) and 895.22(a)....................................... 26 1 26 16 416
Total..................................................... ................ ................ ................ ................ 441
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(k)................................................ 1 1 1 20 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8507 Filed 4-9-12; 8:45 am]
BILLING CODE 4160-01-P
