Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices, 55394-55396 [2011-22858]
Download as PDF
<![CDATA[
55394
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name or module
Household member 18 yrs or older ................
Children ages 3–15 .........................................
Eligibility Screener ..........................................
Baseline: Session 1 .......................................
(Child Modules) ..............................................
Baseline: Session 1 (Parent Modules) ..........
Baseline: Session 2 .......................................
(Child Modules) ..............................................
Baseline: Session 2 .......................................
(Parent Modules) ............................................
6-month Follow-up: Session 1 (Child Modules).
6-month Follow-up: Session 1 (Parent Modules).
6-month Follow-up: Session 2 (Child Modules).
6-month Follow-up: Session 2 (Parent Modules).
Verification Questionnaire for Eligibility
Screener (10% subsample).
Verification Questionnaire for Baseline and
6-month Follow-up Visits (9% subsample).
Mail Verification Form for Baseline and 6month Follow-up Visits (1% subsample).
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Household member 18 yrs or older ................
Household member 18 yrs or older ................
Household member 18 yrs or older ................
Dated: August 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the
Community Preventive Services Task
Force (Task Force). The Task Force—an
independent, nonfederal body of
nationally known leaders in public
health practice, policy, and research
who are appointed by the CDC
Director—was convened in 1996 by the
Department of Health and Human
Services (HHS) to assess the
effectiveness of community,
environmental, population, and
healthcare system interventions in
public health and health promotion.
During this meeting, the Task Force will
consider the findings of systematic
reviews and issue recommendations and
emcdonald on DSK5VPTVN1PROD with NOTICES
Jkt 223001
1
1
10/60
15/60
250
250
1
1
1
1
250
1
30/60
225
1
7/60
225
1
40/60
225
1
37/60
225
1
30/60
112
1
2/60
43
1
5/60
5
1
5/60
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings. The Task
Force’s recommendations, along with
the systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
practice, and research in a wide range
of U.S. settings.
Matters to be discussed: Updates on
Tobacco, Skin Cancer, Health Equity
and Cardiovascular Disease.
Meeting Accessibility: This meeting is
open to the public, limited only by
space availability.
Dated: August 25, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
The Task Force Meeting
will be held at the Centers for Disease
Control and Prevention, Century Center,
2500 Century Parkway, Conference
Rooms 1200/1201, Atlanta, Georgia
30345. Information regarding logistics
will be available on the Community
Guide Web site (https://
www.thecommunityguide.org),
Wednesday, September 14, 2011.
[FR Doc. 2011–22801 Filed 9–6–11; 8:45 am]
ADDRESSES:
Meeting of the Task Force on
Community Preventive Services
17:37 Sep 06, 2011
1,118
250
The meeting will be held on
Monday, October 3, 2011 from 8:30 a.m.
to 5:30 p.m., EST and Tuesday, October
4, 2011 from 8:30 a.m. to 1 p.m. EST.
BILLING CODE 4163–18–P
VerDate Mar<15>2010
Average
burden per
response
(in hours)
DATES:
[FR Doc. 2011–22788 Filed 9–6–11; 8:45 am]
SUMMARY:
Number of
responses per
respondent
Number of
respondents
Respondent
FOR FURTHER INFORMATION CONTACT:
Linda Shelton, The Community Guide
Branch, Epidemiology and Analysis
Program Office, Office of Surveillance,
Epidemiology, and Laboratory Services,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS–E–
69, Atlanta, Georgia 30333, phone: (404)
498–1194), e-mail:
communityguide@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The purpose of the meeting
is for the Task Force to consider the
findings of systematic reviews and issue
recommendations and findings to help
inform decision making about policy,
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0619]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian 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
SUMMARY:
E:\FR\FM\07SEN1.SGM
07SEN1
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
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
humanitarian use devices (HUDs).
DATES: Submit either electronic or
written comments on the collection of
information by November 7, 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.
Medical Devices: Humanitarian Use
Devices—21 CFR Part 814 (OMB
Control Number 0910–0332)—Extension
This collection of information
implements the HUD provision of
section 520(m) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(m)) and subpart H, part
814 (21 CFR part 814). Under section
520(m) of the FD&C Act, FDA is
authorized to exempt an HUD from the
effectiveness requirements of sections
55395
514 and 515 of the FD&C Act (21 U.S.C.
360d and 360e) provided that the
device: (1) Is used to treat or diagnose
a disease or condition that affects fewer
than 4,000 individuals in the United
States; (2) would not be available to a
person with such a disease or condition
unless an exemption is granted because
there is no comparable device other
than another HUD approved under this
exemption that is available to treat or
diagnose the disease or condition; and
(3) will not expose patients to an
unreasonable or significant risk of
illness or injury with the probable
benefit to health from using the device
outweighing the risk of injury or illness
from its use. This takes into account the
probable risks and benefits of currently
available devices or alternative forms of
treatment.
The information collected will assist
FDA in making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt an HUD from the effectiveness
requirements under sections 514 and
515 of the FD&C Act, provided that the
device meets requirements set forth
under section 520(m) of the FD&C Act;
and (3) whether to grant marketing
approval(s) for the HUD. Failure to
collect this information would prevent
FDA from making a determination on
the factors listed previously in this
document. Further, the collected
information would also enable FDA to
determine whether the holder of an
HUD is in compliance with the HUD
provisions under section 520(m) of the
FD&C Act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Total annual
responses
Average burden
per response
Total hours
814.102 ............................................................
814.104 ............................................................
814.106 ............................................................
814.108 ............................................................
814.116(e)(3) ...................................................
814.124(a) ........................................................
814.124(b) ........................................................
814.126(b)(1) ...................................................
17
5
5
47
3
22
12
43
1
1
5
1
1
1
1
1
17
5
25
47
3
22
12
43
40
320
50
80
1
1
2
120
680
1,600
1,250
3,760
3
22
24
5,160
Total ..........................................................
............................
............................
............................
............................
12,499
emcdonald on DSK5VPTVN1PROD with NOTICES
1 There
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
814.126(b)(2) ...................................................
43
1
43
2
86
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
17:37 Sep 06, 2011
Jkt 223001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\07SEN1.SGM
07SEN1
55396
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
The number of respondents in tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
fiscal years 2008 to 2010. The number
of annual reports submitted under
§ 814.126(b)(1) in table 1 reflects 43
respondents with approved HUD
applications. Likewise, under
§ 814.126(b)(2) in table 2, the number of
recordkeepers is 43.
Dated: September 1, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–22858 Filed 9–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
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
the reporting requirements contained in
existing FDA regulations regarding the
general administrative procedures for a
person to petition the Commissioner of
Food and Drugs (the Commissioner) to
issue, amend, or revoke a rule; to file a
petition for an administrative
reconsideration or an administrative
stay of action; and to request an
advisory opinion from the
Commissioner.
DATES: Submit either electronic or
written comments on the collection of
information by November 7, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
emcdonald on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:37 Sep 06, 2011
Jkt 223001
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: 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: 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.
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions—(OMB Control
Number 0910–0183)—Extension
The Administrative Procedures Act (5
U.S.C. 553(e)), provides that every
Agency shall give an interested person
the right to petition for issuance,
amendment, or repeal of a rule. Section
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
10.30 (21 CFR 10.30) sets forth the
format and procedures by which an
interested person may submit to FDA, in
accordance with § 10.20 (21 CFR 10.20)
(submission of documents to Division of
Dockets Management), a citizen petition
requesting the Commissioner to issue,
amend, or revoke a regulation or order,
or to take or refrain from taking any
other form of administrative action.
The Commissioner may grant or deny
such a petition, in whole or in part, and
may grant such other relief or take other
action as the petition warrants.
Respondents are individuals or
households, State or local governments,
not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 371(a)), sets forth
the format and procedures by which an
interested person may request
reconsideration of part or all of a
decision of the Commissioner on a
petition submitted under 21 CFR 10.25
(initiation of administrative
proceedings). A petition for
reconsideration must contain a full
statement in a well-organized format of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision involved.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals of
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting from the
Commissioner a reconsideration of a
matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the FD&C Act,
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20 (submission
of documents to Division of Dockets
Management), the Commissioner to stay
the effective date of any administrative
action.
Such a petition must do the following:
(1) Identify the decision involved; (2)
state the action requested, including the
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55394-55396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0619]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices: Humanitarian 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
[[Page 55395]]
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 humanitarian use devices (HUDs).
DATES: Submit either electronic or written comments on the collection
of information by November 7, 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.
Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control
Number 0910-0332)--Extension
This collection of information implements the HUD provision of
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814).
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an
HUD from the effectiveness requirements of sections 514 and 515 of the
FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is
used to treat or diagnose a disease or condition that affects fewer
than 4,000 individuals in the United States; (2) would not be available
to a person with such a disease or condition unless an exemption is
granted because there is no comparable device other than another HUD
approved under this exemption that is available to treat or diagnose
the disease or condition; and (3) will not expose patients to an
unreasonable or significant risk of illness or injury with the probable
benefit to health from using the device outweighing the risk of injury
or illness from its use. This takes into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The information collected will assist FDA in making determinations
on the following: (1) Whether to grant HUD designation of a medical
device; (2) exempt an HUD from the effectiveness requirements under
sections 514 and 515 of the FD&C Act, provided that the device meets
requirements set forth under section 520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s) for the HUD. Failure to collect
this information would prevent FDA from making a determination on the
factors listed previously in this document. Further, the collected
information would also enable FDA to determine whether the holder of an
HUD is in compliance with the HUD provisions under section 520(m) of
the FD&C Act.
FDA estimates the burden of this collection of information as
follows:
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.102....................................................... 17 1 17 40 680
814.104....................................................... 5 1 5 320 1,600
814.106....................................................... 5 5 25 50 1,250
814.108....................................................... 47 1 47 80 3,760
814.116(e)(3)................................................. 3 1 3 1 3
814.124(a).................................................... 22 1 22 1 22
814.124(b).................................................... 12 1 12 2 24
814.126(b)(1)................................................. 43 1 43 120 5,160
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 12,499
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(2)............................................ 43 1 43 2 86
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 55396]]
The number of respondents in tables 1 and 2 of this document are an
average from data for the previous 3 years, i.e., fiscal years 2008 to
2010. The number of annual reports submitted under Sec. 814.126(b)(1)
in table 1 reflects 43 respondents with approved HUD applications.
Likewise, under Sec. 814.126(b)(2) in table 2, the number of
recordkeepers is 43.
Dated: September 1, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-22858 Filed 9-6-11; 8:45 am]
BILLING CODE 4160-01-P
