Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval, 52388-52389 [2022-18326]
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Federal Register / Vol. 87, No. 164 / Thursday, August 25, 2022 / Notices
to schedule site visit activities prior to
each annual site visit.
• Two Site Visit Discussion Guides:
To systematically document the
approaches and strategies used by the
first two cohorts of CWCC grantees
(fiscal year (FY) 18 and FY 19
visits. Each grantee will participate in
four site visits in total. As noted above,
the first two have already been
completed.
Respondents: Leadership and staff
from CWCC lead (grantee) organizations
and from partner organizations.
awardees), the evaluation team will
conduct follow-up interviews with: (1)
Project Directors from lead grantee
organizations and leaders from partner
organizations, and (2) Staff from the
lead and partner organizations. These
interviews will take place during site
ANNUAL BURDEN ESTIMATES
Total number
of respondents
(over request
period)
Instrument
Cohort 1
Cohort 2
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Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–18327 Filed 8–24–22; 8:45 am]
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Annual burden
(in hours)
12
1
1.5
18
9
36
4
268
4
1
1
1
1
1
1
.5
2
36
4
134
8
18
2
67
4
27
2
1.5
81
41
81
9
990
9
2
2
2
2
1
1
.5
2
162
18
990
36
81
9
495
18
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
AGENCY:
Food and Drug Administration,
HHS.
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
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
26, 2022.
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
SUMMARY:
PO 00000
Total burden
(in hours)
Data Collection for FY19 grantees
Site Visit Discussion Guide for Project Directors and Leaders from Partner Organizations—Follow-Up Interviews ...
Site Visit Discussion Guide for Staff from Lead and Partner Organizations—Follow-Up Interviews ........................
Survey Invitee Template ......................................................
Annual Collaboration Survey ...............................................
Site Visit Planning Template ................................................
ACTION:
Average
burden hours
per response
(in hours)
Data Collection for FY 18 grantees
Site Visit Discussion Guide for Project Directors and Leaders from Partner Organizations—Follow-Up Interviews ...
Site Visit Discussion Guide for Staff from Lead and Partner Organizations—Follow-Up Interviews ........................
Survey Invitee Template ......................................................
Annual Collaboration Survey ...............................................
Site Visit Planning Template ................................................
Estimated Total Annual Burden
Hours: 744.
Comments: The Department
specifically requests comments on (a)
whether the proposed continued
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Authority: Section 105(b)(5) of the
Child Abuse Prevention and Treatment
Act of 1978 (42 U.S.C. 5106(b)(5)), as
amended by the CAPTA
Reauthorization Act of 2010 (Pub. L.
111–320).
Number of
responses per
respondent
(total over
request period)
Frm 00030
Fmt 4703
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Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0264. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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:
Export of Medical Devices; Foreign
Letters of Approval
OMB Control Number 0910–0264—
Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
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Federal Register / Vol. 87, No. 164 / Thursday, August 25, 2022 / Notices
intended for export. Requesters
communicate (either directly or through
a business associate in the foreign
country) with a representative of the
foreign government to which they seek
exportation, and written authorization
must be obtained from the appropriate
office within the foreign government
approving the importation of the
medical device.
An alternative to obtaining written
authorization from the foreign
government is to accept a notarized
certification from a responsible
company official in the United States
that the product is not in conflict with
the foreign country’s laws. This
certification must include a statement
acknowledging that the responsible
company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
52389
the jurisdiction of a department or
Agency of the United States.
Respondents to this collection of
information are companies that seek to
export medical devices.
In the Federal Register of January 28,
2022 (87 FR 4609) we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity and FD&C Act section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total hours
Total operating
and
maintenance
costs
Foreign letter of approval—801(e)(2) ......
36
1
36
2
72
$8,250
1 There
are no capital costs associated with this collection of information.
Our estimate of the reporting burden
is based on our experience with the
information collection and reflects an
overall decrease of 27 hours and a
corresponding increase of three
responses. We attribute this adjustment
to an increase in the number of
submissions received.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18326 Filed 8–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 24, 2022.
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SUMMARY:
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16:25 Aug 24, 2022
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Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Membership Forms for Organ
Procurement (OPTN) and
Transplantation Network OMB No.
0915–0184¥ Revision.
Abstract: Membership in the OPTN is
determined by submission of
application materials to the OPTN (not
to HRSA) demonstrating that the
applicant meets all required criteria for
membership and will agree to comply
with all applicable provisions of the
National Organ Transplant Act, as
amended, 42 U.S.C. 273, et seq., the
OPTN final rule, OPTN Policies, and
OPTN Bylaws. Section 1138 of the
Social Security Act, as amended, 42
U.S.C. 1320b–8 (section 1138) requires
that hospitals in which transplants are
performed by members of, and abide by,
the rules and requirements of the OPTN
(that have been approved by the
Secretary of HHS) as a condition of
participation in Medicare and Medicaid.
Need and Proposed Use of the
Information: The application materials
ADDRESSES:
PO 00000
Frm 00031
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are needed to ensure that all members
and prospective members of the OPTN
submit evidence that they meet the
required qualifications for membership.
These materials provide the OPTN with
information to permit the OPTN to
confirm and demonstrate that applicants
meet OPTN membership application
requirements and to create a record of
the application review process and
resulting actions for consideration by
the Secretary of HHS if an applicant
subsequently appeals a membership
rejection by the OPTN.
This is a request to revise the current
OPTN data collection associated with
transplant hospitals, organ procurement
organizations, transplant
histocompatibility laboratories,
medical/scientific and public
organizations, business organizations,
and individuals to meet or sustain
requirements for OPTN membership to
include data collection forms for OPTN
member hospitals requesting HIV Organ
Policy Equity (HOPE) Act Variances and
Kidney Paired Donation Pilot Program
(KPDPP) contact update form. This
revision also includes changes to the
existing OMB data collection forms.
HRSA is submitting the following
changes to the Membership forms to
clarify requirements and eliminate
redundancy while adding more
explanatory language and instruction to
the applications, which include:
(1) Adding two new data collection
forms for HOPE Act Variance Request
and KPDPP contact update form. The
HOPE Act Variance Request is for any
OPTN member transplant program that
wishes to start a variance to receive
HIV-positive organs for their HIVpositive patients. The KPDPP contact
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]]>Agencies
[Federal Register Volume 87, Number 164 (Thursday, August 25, 2022)]
[Notices]
[Pages 52388-52389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18326]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0370]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Medical
Devices; Foreign Letters of Approval
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: Submit written comments (including recommendations) on the
collection of information by September 26, 2022.
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 0910-0264. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Export of Medical Devices; Foreign Letters of Approval
OMB Control Number 0910-0264--Extension
Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(e)(2)) provides for the exportation of an
unapproved device under certain circumstances if the exportation is not
contrary to the public health and safety and it has the approval of the
foreign country to which it is
[[Page 52389]]
intended for export. Requesters communicate (either directly or through
a business associate in the foreign country) with a representative of
the foreign government to which they seek exportation, and written
authorization must be obtained from the appropriate office within the
foreign government approving the importation of the medical device.
An alternative to obtaining written authorization from the foreign
government is to accept a notarized certification from a responsible
company official in the United States that the product is not in
conflict with the foreign country's laws. This certification must
include a statement acknowledging that the responsible company official
making the certification is subject to the provisions of 18 U.S.C.
1001. This statutory provision makes it a criminal offense to knowingly
and willingly make a false or fraudulent statement, or make or use a
false document, in any manner within the jurisdiction of a department
or Agency of the United States. Respondents to this collection of
information are companies that seek to export medical devices.
In the Federal Register of January 28, 2022 (87 FR 4609) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total operating
Activity and FD&C Act section Number of responses per Total annual Average burden Total hours and maintenance
respondents respondent responses per response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--801(e)(2)............. 36 1 36 2 72 $8,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Our estimate of the reporting burden is based on our experience
with the information collection and reflects an overall decrease of 27
hours and a corresponding increase of three responses. We attribute
this adjustment to an increase in the number of submissions received.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18326 Filed 8-24-22; 8:45 am]
BILLING CODE 4164-01-P
