Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices, 53257-53259 [E9-24921]
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
Part VI is a provision ‘‘sunsetting’’ the
order after twenty (20) years, with
certain exceptions.
The purpose of the analysis is to
facilitate public comment on the
proposed order. It is not intended to
constitute an official interpretation of
the agreement and proposed order or to
modify in any way their terms.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. E9–24996 Filed 10–15–09; 9:30 am]
BILLING CODE 6750–01–S
GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0228]
Office of Civil Rights; Submission for
OMB Review; Nondiscrimination in
Federal Financial Assistance Programs
Office of Civil Rights, GSA.
Notice of request for comments
regarding a renewal to an existing OMB
clearance.
AGENCY:
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the General Services
Administration will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
a previously approved information
collection requirement regarding
nondiscrimination in Federal financial
assistance programs. This information is
needed to facilitate nondiscrimination
in GSA’s Federal Financial Assistance
Programs, consistent with Federal civil
rights laws and regulations that apply to
recipients of Federal financial
assistance.
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate and
based on valid assumptions and
methodology; and ways to enhance the
quality, utility, and clarity of the
information to be collected.
DATES: Submit comments on or before:
November 16, 2009.
FOR FURTHER INFORMATION CONTACT:
Sloan Farrell, Compliance Officer,
Office of Civil Rights, at telephone (202)
501–4347 or via e-mail to
sloan.farrell@gsa.gov.
Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to the Regulatory Secretariat
ADDRESSES:
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16:37 Oct 15, 2009
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53257
(MVPR), General Services
Administration, 1800 F Street, NW.,
Room 4041, Washington, DC 20405.
Please cite OMB Control No. 3090–0228,
Nondiscrimination in Federal Financial
Assistance Programs, in all
correspondence.
Dated: October 8, 2009.
Casey Coleman,
Chief Information Officer.
[FR Doc. E9–24879 Filed 10–15–09; 8:45 am]
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Purpose
The General Services Administration
(GSA) has mission responsibilities
related to monitoring and enforcing
compliance with Federal civil rights
laws and regulations that apply to
Federal Financial Assistance programs
administered by GSA. Specifically,
those laws provide that no person on
the ground of race, color, national
origin, disability, sex or age shall be
excluded from participation in, be
denied the benefits of, or be otherwise
subjected to discrimination under any
program in connection with which
Federal financial assistance is extended
under laws administered in whole or in
part by GSA. These mission
responsibilities generate the
requirement to request and obtain
certain data from recipients of Federal
surplus property for the purpose of
determining compliance, such as the
number of individuals, based on race
and ethnic origin, of the recipient’s
eligible and actual serviced population;
race and national origin of those denied
participation in the recipient’s
program(s); non-English languages
encountered by the recipient’s
program(s) and how the recipient is
addressing meaningful access for
individuals that are Limited English
Proficient; whether there has been
complaints or lawsuits filed against the
recipient based on prohibited
discrimination and whether there has
been any findings; and whether the
recipient’s facilities are accessible to
qualified individuals with disabilities.
B. Annual Reporting Burden
Respondents: 200.
Responses per Respondent: 1.
Total Responses: 200.
Hours per Response: 2.
Total Burden Hours: 400.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 3090–0228,
Nondiscrimination in Federal Financial
Assistance Programs, in all
correspondence.
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BILLING CODE 6820–34–P
Food and Drug Administration
[Docket No. FDA–2009–N–0475]
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 requirements for
administrative detention and banned
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by December 15, 2009.
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793,
Denver.Presley@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16OCN1.SGM
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53258
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
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 act) (21 U.S.C.
334(g)), to detain during established
inspections, devices that are believed to
be adulterated or misbranded. FDA
issued a final rule that published in a
March 9, 1979, Federal Register (44 FR
13234) on administrative detention
procedures, which includes among
other things, certain reporting
requirements and recordkeeping
requirements under § 800.55(g) and (k),
(21 CFR 800.55(g) and (k)). 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 pemits 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 act (21 U.S.C.
360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. The final rule for
banned devices that published in the
May 18, 1979, Federal Register (44 FR
29221) contained certain reporting
requirements under 21 CFR 895.21(d)
and 895.22(a). Section 895.21(d) states
that if the Commissioner of Food and
Drugs Administration (the
Commissioner), decides to initiate a
proceeding to make a device, ‘‘ a banned
device,’’ a notice of proposed
rulemaking will be published in the
Federal Register and this document will
contain the finding that the device
presents a substantial deception or an
unreasonable and substantial risk of
illness or injury. The document will
also contain the reasons why the
proceeding was initiated, an evaluation
of data and information obtained under
other provisions of the act, any
consultations with the panel, and a
determination as to whether the device
could be corrected by labeling, change
of labeling, change of advertising, and if
that labeling or change of advertising
has been made. Under § 895.21(d), any
interested person may request an
informal hearing and submit written
comments. Under § 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
800.55(g)
Total Annual
Responses
Hours per
Response
Total Hours
1
1
25
25
26
895.21(d) and 895.22(a)
1
1
26
16
416
Totals
1There
441
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual Frequency
per Recordkeeping
No. of
Recordkeepers
21 CFR Section
800.55(k)
1
Total Annual
Records
1
Hours per
Recordkeeper
1
20
jlentini on DSKJ8SOYB1PROD with NOTICES
Totals
1There
Total Hours
20
461
are no capital costs or operating and maintenance costs associated with this collection of information.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
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have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
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based on FDA’s discussion with one of
three firms whose devices had been
detained.
E:\FR\FM\16OCN1.SGM
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
Dated: October 8, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24921 Filed 10–15–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Evaluation of the
NIAID HIV Vaccine Research Education
Initiative
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Allergy and Infectious
Diseases (NIAID), the National Institutes
of Health (NIH) has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on July 16, 2009, page 34580
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Evaluation
of the NIAID HIV Vaccine Research
Education Initiative. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
To address the need for volunteers in
HIV vaccine clinical trials, and enable
NIAID to fulfill its Congressional
mandate to prevent infectious diseases
like HIV/AIDS, NIAID created the
NIAID HIV Vaccine Research Education
Initiative (NHVREI). The goal of
NHVREI is to increase knowledge about
and support for HIV vaccine research
among U.S. populations most heavily
affected by HIV/AIDS—in particular,
African Americans, Hispanics/Latinos,
men who have sex with men (MSM),
women and youth, recognizing the
intersection of these groups.
NIAID is planning an evaluation of
NHVREI to assess (a) implementation of
NHVREI (i.e., process evaluation) and
(b) impact (i.e., outcomes evaluation) of
NHVREI on awareness of, knowledge
about, and support for HIV vaccine
research among NHVREI primary
audiences (i.e., partner organizations,
Type of respondents
LPP, NPP, and NHVREI Network ....
Key Influencers .................................
jlentini on DSKJ8SOYB1PROD with NOTICES
LPP, NPP, and NHVREI Network ....
Key Influencers .................................
Time 1
Focus Groups ...................................
Survey ..............................................
Total Time 1 .....................................
Time 2
Focus Groups ...................................
Survey ..............................................
Total Time 2 .....................................
Total Time 1 & Time 2 .....................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
VerDate Nov<24>2008
16:37 Oct 15, 2009
Jkt 220001
Average burden hours per
response
Estimated total
annual burden
hours
requested
78
656
734
1
1
........................
1
0.33
........................
78
216
294
78
590
668
1,402
1
1
........................
........................
1
0.33
........................
........................
78
195
273
567
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
key influencers) that work with target
populations.
A survey will be conducted with key
influencers of the NHVREI target
populations to measure their level of
awareness, knowledge about, and
support for HIV vaccine research. Focus
groups will also be conducted with
representatives of organizations
receiving grants through the NHVREI
Local Partnership Program (LPP) and
National Partnership Program (NPP), as
well as representatives from a broader
group of organizations called the
NHVREI Network. The purpose of
conducting focus groups with LPP, NPP,
and NHVREI Network representatives is
to obtain data on their experience
implementing NHVREI activities.
Questions asked during the group
discussions will address efforts
implementing educational activities and
developing materials, community
partnerships developed, engagement of
key influencers in program activities,
and the types of media outreach and
capacity building engaged in. Frequency
of Response: Twice. Affected Public:
Individuals. Type of Respondents: Key
influencers of target populations. The
annual reporting burden is shown in the
table below. There are no Capital Costs
to report. There are no Operating or
Maintenance Costs to report.
No. of responses per
respondent
Estimated
number of
respondents
Form name
53259
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact
Katharine Kripke, Assistant Director,
Vaccine Research Program, Division of
AIDS, NIAID, NIH, 6700B Rockledge
Dr., Bethesda, MD 20892–7628, or call
non-toll-free number 301–402–0846, or
E-mail your request, including your
address to NIAIDSurvey@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
E:\FR\FM\16OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53257-53259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24921]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0475]
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
requirements for administrative detention and banned medical devices.
DATES: Submit written or electronic comments on the collection of
information by December 15, 2009.
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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793,
Denver.Presley@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
[[Page 53258]]
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 act) (21 U.S.C. 334(g)), to detain
during established inspections, devices that are believed to be
adulterated or misbranded. FDA issued a final rule that published in a
March 9, 1979, Federal Register (44 FR 13234) on administrative
detention procedures, which includes among other things, certain
reporting requirements and recordkeeping requirements under Sec.
800.55(g) and (k), (21 CFR 800.55(g) and (k)). 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
pemits 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 act
(21 U.S.C. 360f) to ban devices that present substantial deception or
an unreasonable and substantial risk of illness or injury. The final
rule for banned devices that published in the May 18, 1979, Federal
Register (44 FR 29221) contained certain reporting requirements under
21 CFR 895.21(d) and 895.22(a). Section 895.21(d) states that if the
Commissioner of Food and Drugs Administration (the Commissioner),
decides to initiate a proceeding to make a device, `` a banned
device,'' a notice of proposed rulemaking will be published in the
Federal Register and this document will contain the finding that the
device presents a substantial deception or an unreasonable and
substantial risk of illness or injury. The document will also contain
the reasons why the proceeding was initiated, an evaluation of data and
information obtained under other provisions of the act, any
consultations with the panel, and a determination as to whether the
device could be corrected by labeling, change of labeling, change of
advertising, and if that labeling or change of advertising has been
made. Under Sec. 895.21(d), any interested person may request an
informal hearing and submit written comments. Under Sec. 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.
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
----------------------------------------------------------------------------------------------------------------
800.55(g) 1 1 1 25 25
----------------------------------------------------------------------------------------------------------------
895.21(d) and 26 1 26 16 416
895.22(a)
----------------------------------------------------------------------------------------------------------------
Totals 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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
800.55(k) 1 1 1 20 20
----------------------------------------------------------------------------------------------------------------
Totals 461
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
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.
[[Page 53259]]
Dated: October 8, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24921 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S
