Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 63806-63807 [2015-26641]
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63806
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDRH Appeals Processes Guidance Document ................
50
1
50
8
400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26672 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
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 Inspection by Accredited Persons
Program Under the Medical Device User
Fee and Modernization Act of 2002.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2015.
ADDRESSES: You may submit comments
as follows:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions’’.
Instructions: All submissions received
must include the Docket No.FDA–2012–
N–0427 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Devices; Inspection by Accredited
Persons Program’’. Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
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.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—OMB Control Number 0910–
0510—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
63807
(Pub. L. 107–250) was signed into law
on October 26, 2002. Section 201 of
MDUFMA added a new paragraph (g) to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (21 U.S.C. 374),
directing FDA to accredit third parties
(accredited persons) to conduct
inspections of eligible manufacturers of
class II or class III devices. FDA’s
guidance document entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria’’ provides
information for those interested in
participating in this voluntary program.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for accreditation .....................................................
1
1
1
80
80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26641 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Meeting Notice for the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships announces
the following meetings:
Name: President’s Advisory Council
on Faith-based and Neighborhood
Partnerships Council Meetings
Time and Date: Thursday, November
5th, 2015 1:00 p.m.–4:30 p.m. (EST) and
Friday, November 6th, 2015 9:30 a.m.–
12:30 p.m. (EST)
Place: Meeting will be held at a
location to be determined in the White
House complex, 1600 Pennsylvania
Ave. NW., Washington, DC. Space is
extremely limited. Photo ID and RSVP
are required to attend the event. Please
RSVP to Ben O’Dell at partnerships@
hhs.gov
The meeting will be available to the
public through a conference call line.
Register to participate in the conference
call on Thursday, November 5th at the
Web site https://
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
attendee.gotowebinar.com/register/
7500158409923624193. Register to
participate in the conference call on
Friday, November 6th at the Web site
https://attendee.gotowebinar.com/
register/8566024981889767937.
Status: Open to the public, limited
only by space available. Conference call
limited only by lines available.
Purpose: The Council brings together
leaders and experts in fields related to
the work of faith-based and
neighborhood organizations in order to:
Identify best practices and successful
modes of delivering social services;
evaluate the need for improvements in
the implementation and coordination of
public policies relating to faith-based
and other neighborhood organizations;
and make recommendations for changes
in policies, programs, and practices.
Contact Person for Additional
Information: Please contact Ben O’Dell
for any additional information about the
President’s Advisory Council meeting at
partnerships@hhs.gov
Agenda: More information for the
agenda for the meeting will be provided
to those who register to attend in person
or by conference call.
Public Comment: There will be an
opportunity for public comment at the
end of the meeting. Comments and
questions can be sent in advance to
partnerships@hhs.gov.
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Fmt 4703
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Dated: October 9, 2015.
Ben O’Dell,
Associate Director.
[FR Doc. 2015–26407 Filed 10–20–15; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Collaborative Research in Integrative Cancer
Biology (U01).
Date: November 19, 2015.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63806-63807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26641]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0427]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Inspection by Accredited Persons
Program
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 the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002.
DATES: Submit either electronic or written comments on the collection
of information by December 21, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions''.
Instructions: All submissions received must include the Docket
No.FDA-2012-N-0427 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Inspection by
Accredited Persons Program''. Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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
[[Page 63807]]
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.
Inspection by Accredited Persons Program Under the Medical Device User
Fee and Modernization Act of 2002--OMB Control Number 0910-0510--
Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201
of MDUFMA added a new paragraph (g) to section 704 of the Federal,
Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit
third parties (accredited persons) to conduct inspections of eligible
manufacturers of class II or class III devices. FDA's guidance document
entitled ``Implementation of the Inspection by Accredited Persons
Program Under the Medical Device User Fee and Modernization Act of
2002; Accreditation Criteria'' provides information for those
interested in participating in this voluntary program.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for accreditation.......................................... 1 1 1 80 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26641 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P
