Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls Guidance Document: Labeling of Natural Rubber Latex Condoms, 4273-4274 [2015-01403]
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Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
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.
Biosimilars User Fee Cover Sheet; Form
FDA 3792 (OMB Control Number 0910–
0718)—Extension
The Patient Protection and Affordable
Care Act (Pub. L. 111–148) contains a
subtitle called the Biologics Price
Competition and Innovation Act of 2009
(Title VII Subtitle A) (BPCI Act) that
amends the Public Health Service Act
(42 U.S.C. 262) (PHS Act) and other
statutes to create an abbreviated
approval pathway for biological
products shown to be biosimilar to or
interchangeable with an FDA-licensed
reference biological product. Section
351(k) of the PHS Act, added by the
BPCI Act, allows a company to submit
an application for licensure of a
biosimilar or interchangeable biological
product. The BPCI Act also amends
section 735 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g) to
include 351(k) applications in the
definition of ‘‘human drug application’’
for the purposes of the prescription drug
user fee provisions. The BPCI Act
directs FDA to develop
recommendations for a biosimilar
biological product user fee program for
fiscal years 2013 through 2017. FDA’s
recommendations for a biosimilar
biological product user fee program
were submitted to Congress on January
13, 2012.
FDA’s biosimilar biological product
user fee program requires FDA to assess
and collect user fees for certain
meetings concerning biosimilar
4273
biological product development (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biological
product applications and supplements.
Form FDA 3792, the Biosimilars User
Fee Cover Sheet, requests the minimum
necessary information to determine the
amount of the fee required, and to
account for and track user fees. The
form provides a cross-reference of the
fees submitted for a submission with the
actual submission by using a unique
number tracking system. The
information collected is used by FDA’s
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs, applications, and
supplements, and to account for and
track user fees associated with BPD
meetings.
Respondents to this collection of
information are manufacturers of
biosimilar biological product
candidates. Based on the number of
Form FDA 3792s we have received, we
estimate the burden of this collection of
information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Biosimilars User Fee Cover Sheet; Form FDA 3792 ..
20
1
20
0.50 (30 minutes) ...
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[FR Doc. 2015–01404 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by February
26, 2015.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1414]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Class II Special
Controls Guidance Document:
Labeling of Natural Rubber Latex
Condoms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
18:01 Jan 26, 2015
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Notice.
VerDate Sep<11>2014
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.
ADDRESSES:
Jkt 235001
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\27JAN1.SGM
27JAN1
4274
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
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), which 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 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
five new manufacturers or repackagers
to enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. The
number of respondents cited in table 1
of this document is based on FDA’s
database of premarket submissions and
the electronic registration and listing
database. The average burden per
disclosure was 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 previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807 subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
The collection of information under
21 CFR 801.437 does not constitute a
‘‘collection of information’’ under the
Paperwork Reduction Act of 1995.
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 October 15,
2014 (79 FR 61874), 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
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300 .............
5
1
5
12
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Consensus Standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 038’’ (Recognition List
Number: 038), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
[FR Doc. 2015–01403 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
038
Submit either electronic or
written comments concerning this
document at any time. See section VII
of this document for the effective date
of the recognition of standards
announced in this document.
ADDRESSES:
DATES:
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA Recognized
SUMMARY:
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
An electronic copy of
Recognition List Number: 038 is
available on the Internet at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 038
modifications and other standards
related information.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Submit written requests for a single
copy of the document entitled
‘‘Modifications to the List of Recognized
Standards, Recognition List Number:
038’’ to the Division of Industry and
Consumer Education, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149.
Submit electronic comments on this
document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3632, Silver Spring,
E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4273-4274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1414]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Class II Special
Controls Guidance Document: Labeling of 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 the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 26, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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
[[Page 4274]]
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), which 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
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 five new manufacturers
or repackagers to enter the market yearly and to collectively have a
third-party disclosure burden of 60 hours. The number of respondents
cited in table 1 of this document is based on FDA's database of
premarket submissions and the electronic registration and listing
database. The average burden per disclosure was 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 previously
approved collections of information found in FDA regulations. The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 807 subpart E have been approved under OMB control number 0910-
0120; and the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073.
The collection of information under 21 CFR 801.437 does not
constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995. 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 October 15, 2014 (79 FR 61874), 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
Number of disclosures Total Average
Activity respondents per annual burden per Total hours
respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance 5 1 5 12 60
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21 CFR
884.5300.................................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01403 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P
