Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information, 24628-24629 [2021-09624]
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
respond rapidly to this devastating
pandemic. This supplemental award
will allow NORC to enhance the
capacity of LTC Ombudsman programs
to address abuse, neglect and
exploitation as programs begin to reenter long-term care facilities. This
supplemental is consistent with the
Coronavirus Response and Relief
Supplemental Appropriations Act of
2021: Grants to Enhance Capacity of
Long-Term Care Ombudsman Programs
to Respond to Complaints of Abuse and
Neglect of Residents in Long-Term Care
Facilities during the COVID–19 Public
Health Emergency.
Program Name: National Ombudsman
Resource Center.
Recipient: The National Consumer
Voice for Quality Long-Term Care.
Period of Performance: The
supplement award will be issued for the
time period of April 1, 2021-September
30, 2022.
Total Award Amount: $25,000, FY
2021.
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: This program is
authorized under Section 202 of the
Older Americans Act.
Basis for Award: The objective of the
National Ombudsman Resource Center
is to support credible and effective
Long-Term Care Ombudsman programs
through the provision of technical
assistance and training to state
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agencies on aging. Each year the NORC
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COVID–19 Recover and Re-entry and
Trauma-Informed webinars and
dialogue to assist Ombudsman
programs.
For More Information Contact: For
further information or comments
regarding this program supplement,
contact Louise Ryan, U.S. Department of
Health and Human Services,
Administration for Community Living,
Administration on Aging (206) 615–
2299; email Louise.Ryan@acl.hhs.gov.
Date: April 30, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–09661 Filed 5–6–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0913]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 513(g) Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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: Submit written comments
(including recommendations) on the
collection of information by June 7,
2021.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0705. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
513(g) Request for Information
OMB Control Number 0910–0705—
Extension
This information collection supports
Agency regulations and accompanying
guidance. Section 513(g) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c(g)) provides a
means for obtaining the Agency’s views
about the classification and regulatory
requirements that may be applicable to
a particular device. Section 513(g)
provides that, within 60 days of the
PO 00000
Frm 00047
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Sfmt 4703
receipt of a written request of any
person for information respecting the
class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
Regulations governing medical device
classification procedures are codified
under 21 CFR part 860.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
Under the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry
and Food and Drug Administration
Staff’’ 1 establishes procedures for
submitting, reviewing, and responding
to requests for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act that are
submitted in accordance with section
513(g) of the FD&C Act. FDA does not
review data related to substantial
equivalence or safety and effectiveness
in a 513(g) request for information.
FDA’s responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act.
Relatedly, the FD&C Act, as amended
by the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), requires FDA to collect user fees for
513(g) requests for information. The
guidance document entitled ‘‘User Fees
for 513(g) Requests for Information;
Guidance for Industry and Food and
Drug Administration Staff’’ 2 assists
FDA staff and regulated industry by
describing the user fees associated with
513(g) requests. The Medical Device
User Fee Cover Sheet (Form FDA 3601),
which accompanies the supplemental
material described in this information
collection is approved under OMB
control number 0910–0511.
In the Federal Register of January 13,
2021 (86 FR 2674), FDA published a 60day notice requesting public comment
on the proposed collection of
information. We received five
comments; however, the comments
1 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-informationunder-federal-food-drug-and-cosmetic.
2 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/user-fees-513grequests-information.
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
were not responsive to the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Center for Devices and Radiological Health 513(g) requests ...............................................................................
Center for Biologics Evaluation and Research 513(g) requests ...............................................................................
Total ..............................................................................
1 There
Dated: April 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09624 Filed 5–6–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0336]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Quantitative
Research on a Voluntary Symbol
Depicting the Nutrient Content Claim
‘‘Healthy’’ on Packaged Foods
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
response
Total annual
responses
Total hours
114
1
114
12
1,368
4
1
4
12
48
........................
........................
........................
........................
1,416
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a new collection
of information for a study entitled
‘‘Quantitative Research on a Voluntary
Symbol Depicting the Nutrient Content
Claim ‘Healthy’ on Packaged Foods.’’
DATES: Submit either electronic or
written comments on the collection of
information by July 6, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
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19:55 May 06, 2021
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untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 6, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 6, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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): Dockets
Management Staff (HFA–305), Food and
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Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2021–N–0336 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Quantitative Research on a Voluntary
Symbol Depicting the Nutrient Content
Claim ‘Healthy’ on Packaged Foods.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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 Dockets Management
Staff. 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
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]]>Agencies
[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24628-24629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0913]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 513(g) Request for
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by June 7, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0705. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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.
513(g) Request for Information
OMB Control Number 0910-0705--Extension
This information collection supports Agency regulations and
accompanying guidance. Section 513(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(g)) provides a means for
obtaining the Agency's views about the classification and regulatory
requirements that may be applicable to a particular device. Section
513(g) provides that, within 60 days of the receipt of a written
request of any person for information respecting the class in which a
device has been classified or the requirements applicable to a device
under the FD&C Act, the Secretary of Health and Human Services shall
provide such person a written statement of the classification (if any)
of such device and the requirements of the FD&C Act applicable to the
device. Regulations governing medical device classification procedures
are codified under 21 CFR part 860.
The guidance document entitled ``FDA and Industry Procedures for
Section 513(g) Requests for Information Under the Federal Food, Drug,
and Cosmetic Act; Guidance for Industry and Food and Drug
Administration Staff'' \1\ establishes procedures for submitting,
reviewing, and responding to requests for information respecting the
class in which a device has been classified or the requirements
applicable to a device under the FD&C Act that are submitted in
accordance with section 513(g) of the FD&C Act. FDA does not review
data related to substantial equivalence or safety and effectiveness in
a 513(g) request for information. FDA's responses to 513(g) requests
for information are not device classification decisions and do not
constitute FDA clearance or approval for marketing. Classification
decisions and clearance or approval for marketing require submissions
under different sections of the FD&C Act.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
---------------------------------------------------------------------------
Relatedly, the FD&C Act, as amended by the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to
collect user fees for 513(g) requests for information. The guidance
document entitled ``User Fees for 513(g) Requests for Information;
Guidance for Industry and Food and Drug Administration Staff'' \2\
assists FDA staff and regulated industry by describing the user fees
associated with 513(g) requests. The Medical Device User Fee Cover
Sheet (Form FDA 3601), which accompanies the supplemental material
described in this information collection is approved under OMB control
number 0910-0511.
---------------------------------------------------------------------------
\2\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-information.
---------------------------------------------------------------------------
In the Federal Register of January 13, 2021 (86 FR 2674), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received five comments; however, the
comments
[[Page 24629]]
were not responsive to the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Center for Devices and 114 1 114 12 1,368
Radiological Health 513(g)
requests.......................
Center for Biologics Evaluation 4 1 4 12 48
and Research 513(g) requests...
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,416
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09624 Filed 5-6-21; 8:45 am]
BILLING CODE 4164-01-P
