Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms, 71575-71576 [2011-29839]
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71575
Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices
Estimated Total Annual Burden
Hours: 15,093.
Administration for Children and
Families.
Additional Information
Robert Sargis,
Reports Clearance Officer.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 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. Fax: (202) 395–7285.
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
specific requirements stipulated in 45
CFR 400.4–400.9. The State Plan must
include all applicable State procedures,
designations, and certifications for each
requirement as well as supporting
documentation. A State may use a preprint format prepared by the Office of
Refugee Resettlement (ORR) of the
Administration for Children and
Families (ACF) or a different format, on
the condition that the format used meets
all of the State plan requirements under
Title IV of the Act and ORR regulations
at 45 CFR part 400.
There is no schedule for submission
of this State Plan, as all States are
currently operating under an approved
plan and are in compliance with
regulations at 45 CFR 400.4–400.9. Per
45 CFR 400.4(b), States need only certify
that the approved plan is current and
continues in effect, no later than 30 days
after the beginning of the Federal fiscal
year. Consistent with regulations, if
States wish to revise or amend the plan,
a revised plan or plan amendment must
be submitted to ORR as described at 45
CFR 400.7 400.9.
Respondents: State Agencies,
Replacement Designees under 45 CFR
400.301(c), and Wilson-Fish Grantees
(State 2 Agencies) administering or
supervising the administration of
programs under Title IV of the Act.
[FR Doc. 2011–29811 Filed 11–17–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: State Plan for Grants to States
for Refugee Resettlement.
OMB No.: 0970–0351.
Description: A State Plan is required
by 8 U.S.C. 1522 of the Immigration and
Nationality Act (the Act) [Title IV, Sec.
412 of the Act] for each State agency
requesting Federal funding for refugee
resettlement under 8 U.S.C. 524 [Title
IV, Sec. 414 of the Act], including
Refugee Cash and Medical Assistance,
Refugee Social Services, and Targeted
Assistance program funding. The State
Plan is a comprehensive narrative
description of the nature and scope of
a States programs and provides
assurances that the programs will be
administered in conformity with the
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
Title IV State Plan ............................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
50
1
15
750
Estimated Total Annual Burden
Hours: 750.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 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
VerDate Mar<15>2010
17:44 Nov 17, 2011
Jkt 226001
of Management and Budget, Paperwork
Reduction Project, Fax: (202) 395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–29820 Filed 11–17–11; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0492]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Class II Special
Controls Guidance Document:
Labeling for Natural Rubber Latex
Condoms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
SUMMARY:
Frm 00066
Fmt 4703
Sfmt 4703
E:\FR\FM\18NON1.SGM
18NON1
71576
Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by December
19, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
(202) 395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0633. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21
CFR 884.5300—(OMB Control Number
0910–0633)—Extension
Under the Medical Device
Amendments of 1976 (Pub. L. 94–295),
class II devices were defined as those
devices for which there was insufficient
information to show that general
controls themselves would provide a
reasonable assurance of safety and
effectiveness, but for which there was
sufficient information to establish
performance standards to provide such
assurance.
Condoms without spermicidal
lubricant containing nonoxynol-9 are
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629) that broadened the definition
of class II devices and now permit FDA
to establish special controls beyond
performance standards, including
guidance documents, to help provide
reasonable assurance of the safety and
effectiveness of such devices.
In December 2000, Congress enacted
Public Law 106–554, which among
other provisions, directed FDA to
‘‘reexamine existing condom labels’’
and ‘‘determine whether the labels are
medically accurate regarding the overall
effectiveness or lack of effectiveness in
preventing sexually transmitted diseases
* * *.’’ In response, FDA recommended
labeling intended to provide important
information for condom users, including
the extent of protection provided by
condoms against various types of
sexually transmitted diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately
three new manufacturers or repackagers
to enter the market yearly and
collectively have a third-party
disclosure burden of 1,224 hours. The
number of respondents and prospective
new manufacturers cited in table 1 of
this document are based on FDA’s
database of premarket submissions. The
remaining figures were derived from a
study performed for FDA by Eastern
Research Group, Inc., an economic
consulting firm, to estimate the impact
of the 1999 over-the-counter (OTC)
human drug labeling requirements final
rule (64 FR 13254, March 17, 1999).
Because the packaging requirements for
condoms are similar to those of many
OTC drugs, we believe the burden to
design the labeling for OTC drugs is an
appropriate proxy for the estimated
burden to design condom labeling.
The special controls guidance
document also refers to currently
approved collections of information
found in FDA regulations. The
collections of information under 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information under 21
CFR part 820 have been approved under
OMB control number 0910–0073; and
the collections of information in part
801 (21 CFR part 801) have been
approved under OMB control number
0910–0485.
The collection of information under
§ 801.437 does not constitute a
‘‘collection of information’’ under the
PRA. Rather, it is a ‘‘public disclosure
of information originally supplied by
the Federal Government to the recipient
for the purpose of disclosure to the
public’’ (5 CFR 1320.3(c)(2)).
In the Federal Register of July 8, 2011
(76 FR 40377), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
884.5300 ..............................................................................
3
34
102
12
1,224
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29839 Filed 11–17–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0410]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Premarket Notification for a New
Dietary Ingredient
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:44 Nov 17, 2011
Jkt 226001
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Premarket Notification for a New
Dietary Ingredient’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
SUMMARY:
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71575-71576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0492]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Class II Special
Controls Guidance Document: Labeling for Natural Rubber Latex Condoms
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under
[[Page 71576]]
the Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by
December 19, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: (202) 395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0633.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300--(OMB Control
Number 0910-0633)--Extension
Under the Medical Device Amendments of 1976 (Pub. L. 94-295), class
II devices were defined as those devices for which there was
insufficient information to show that general controls themselves would
provide a reasonable assurance of safety and effectiveness, but for
which there was sufficient information to establish performance
standards to provide such assurance.
Condoms without spermicidal lubricant containing nonoxynol-9 are
classified in class II. They were originally classified before the
enactment of provisions of the Safe Medical Devices Act of 1990 (Pub.
L. 101-629) that broadened the definition of class II devices and now
permit FDA to establish special controls beyond performance standards,
including guidance documents, to help provide reasonable assurance of
the safety and effectiveness of such devices.
In December 2000, Congress enacted Public Law 106-554, which among
other provisions, directed FDA to ``reexamine existing condom labels''
and ``determine whether the labels are medically accurate regarding the
overall effectiveness or lack of effectiveness in preventing sexually
transmitted diseases * * *.'' In response, FDA recommended labeling
intended to provide important information for condom users, including
the extent of protection provided by condoms against various types of
sexually transmitted diseases.
Respondents to this collection of information are manufacturers and
repackagers of male condoms made of natural rubber latex without
spermicidal lubricant. FDA expects approximately three new
manufacturers or repackagers to enter the market yearly and
collectively have a third-party disclosure burden of 1,224 hours. The
number of respondents and prospective new manufacturers cited in table
1 of this document are based on FDA's database of premarket
submissions. The remaining figures were derived from a study performed
for FDA by Eastern Research Group, Inc., an economic consulting firm,
to estimate the impact of the 1999 over-the-counter (OTC) human drug
labeling requirements final rule (64 FR 13254, March 17, 1999). Because
the packaging requirements for condoms are similar to those of many OTC
drugs, we believe the burden to design the labeling for OTC drugs is an
appropriate proxy for the estimated burden to design condom labeling.
The special controls guidance document also refers to currently
approved collections of information found in FDA regulations. The
collections of information under 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information under 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in part 801 (21
CFR part 801) have been approved under OMB control number 0910-0485.
The collection of information under Sec. 801.437 does not
constitute a ``collection of information'' under the PRA. Rather, it is
a ``public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
In the Federal Register of July 8, 2011 (76 FR 40377), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
884.5300........................................................... 3 34 102 12 1,224
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29839 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P
