Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices, 33197-33198 [2014-13435]
Download as PDF
<![CDATA[
33197
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
automatically will be evaluated. Other
commenters questioned FDA’s
implementation and Congress’ intent of
the FSPTCA and its definition of
substantial equivalence and new
products.
(Response 4) The FD&C Act as
amended by the FSPTCA establishes the
definition of ‘‘new tobacco product’’
and the premarket pathways, of which
substantial equivalence is one. FDA
believes the information collection
estimates are appropriate and reflect
estimates of the time it would take to
put together and report the information
needed in a substantial equivalence
submission required by the statute.
(Comment 5) One commenter stated
that the commenter believes that
substantial equivalence reports should
be exempt from environmental
assessment requirements.
(Response 5) The National
Environmental Policy Act and FDA
implementing regulations require
environmental assessment
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act sections
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
905(j)(1)(A)(i) and 910(a) .....................................................
1,000
1
1,000
360
360,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
Food and Drug Administration
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
humanitarian use devices (HUDs).
DATES: Submit either electronic or
written comments on the collection of
information by August 11, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
[Docket No. FDA–2011–N–0619]
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
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
FDA has based these estimates on
information it now has available from
interactions with the industry,
information related to other regulated
products, and FDA’s expectations
regarding the tobacco industry’s use of
the section 905(j) pathway to market
their products. Table 1 describes the
annual reporting burden as a result of
the implementation of the substantial
equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21
U.S.C. 387j(a)). FDA estimates that it
will receive 1,000 section 905(j) reports
each year and that it will take a
manufacturer approximately 360 hours
to prepare a report of substantial
equivalence for a new tobacco product.
Therefore, FDA estimates the burden for
submission of substantial equivalence
information will be 360,000 hours.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13434 Filed 6–9–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
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
SUMMARY:
VerDate Mar<15>2010
16:55 Jun 09, 2014
Jkt 232001
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Medical Devices; Humanitarian Use
Devices—21 CFR 814 (OMB Control
Number 0910–0332)—Extension
E:\FR\FM\10JNN1.SGM
10JNN1
33198
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
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.
The number of respondents in tables
1, 2, and 3 of this document are an
average based on data for the previous
3 years, i.e., fiscal years 2011 through
2013. The number of annual reports
submitted under § 814.126(b)(1) in table
1 reflects 32 respondents with approved
HUD applications. Likewise, under
§ 814.126(b)(2) in table 2, the number of
recordkeepers is 247.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR Section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Request for HUD designation—814.102 .............................
Humanitarian device exemption (HDE) application—
814.104 .............................................................................
HDE amendments and resubmitted HDEs—814.106 .........
HDE supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of institutional review board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
16
1
16
40
640
7
14
112
8
1
5
1
1
7
70
112
8
320
50
80
1
2,240
3,500
8,960
8
3
32
1
1
3
32
2
120
6
3,840
Total ..............................................................................
........................
........................
........................
........................
19,194
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ..............................................
247
1
247
2
494
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR Section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification of emergency use—814.124(a) ........................
22
1
22
1
22
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13435 Filed 6–9–14; 8:45 am]
emcdonald on DSK67QTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–1234]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; STENDRA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
16:55 Jun 09, 2014
Jkt 232001
PO 00000
Submit electronic
comments to https://
ADDRESSES:
Notice.
Frm 00028
Fmt 4703
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
STENDRA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
SUMMARY:
Sfmt 4703
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33197-33198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13435]
-----------------------------------------------------------------------
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 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 August 11, 2014.
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: 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: 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 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
[[Page 33198]]
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.
The number of respondents in tables 1, 2, and 3 of this document
are an average based on data for the previous 3 years, i.e., fiscal
years 2011 through 2013. The number of annual reports submitted under
Sec. 814.126(b)(1) in table 1 reflects 32 respondents with approved
HUD applications. Likewise, under Sec. 814.126(b)(2) in table 2, the
number of recordkeepers is 247.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation-- 16 1 16 40 640
814.102........................
Humanitarian device exemption 7 1 7 320 2,240
(HDE) application--814.104.....
HDE amendments and resubmitted 14 5 70 50 3,500
HDEs--814.106..................
HDE supplements--814.108........ 112 1 112 80 8,960
Notification of withdrawal of an 8 1 8 1 8
HDE--814.116(e)(3).............
Notification of withdrawal of 3 1 3 2 6
institutional review board
approval--814.124(b)...........
Periodic reports--814.126(b)(1). 32 1 32 120 3,840
���������������������������������
Total....................... .............. .............. .............. .............. 19,194
----------------------------------------------------------------------------------------------------------------
\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 Average burden
Activity/21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeping records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2)......................................... 247 1 247 2 494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a).......................... 22 1 22 1 22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13435 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P
