Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs, 70993-70995 [2023-22653]
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70993
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
requirement for evaluation of practices
and programs to improve activities such
as identification, screening, medical
diagnosis, forensic diagnosis, health
evaluations, and services, including
activities that promote collaboration
between (1) the child protective service
system; and (2) (i) the medical
community, including providers of
mental health and developmental
disability services; and (ii) providers of
early childhood intervention services
and special education for children who
have been victims of child abuse or
neglect.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–22676 Filed 10–12–23; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Child Support
Enforcement Direct Funding Request:
(Office of Management and Budget
#0970–0218)
Office of Child Support
Services, Administration for Children
and Families, United States Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Child Support
Services (OCSS), Administration for
Children and Families (ACF) is
requesting proposed revisions to an
approved information collection the
SUMMARY:
Tribal Child Support Enforcement
Direct Funding Requests—(Office of
Management and Budget (OMB) #0970–
0218, expiration March 31, 2026). We
are proposing a new requirement for
tribes or tribal organizations to provide
that charging fees and recovering costs
will not be permitted.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act (PRA) of 1995, ACF is
soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The final rule within 45
CFR part 309, published in the Federal
Register on March 30, 2004, contains a
regulatory reporting requirement that, in
order to receive funding for a tribal IV–
D program, a tribe or tribal organization
must submit a plan describing how the
tribe or tribal organization meets or
plans to meet the objectives of section
455(f) of the Social Security Act,
including establishing paternity;
establishing, modifying, and enforcing
support orders; and locating
noncustodial parents. The plan is
required for all tribes requesting
funding; however, once a tribe has met
the requirements to operate a
comprehensive program, a new plan is
not required annually unless a tribe
makes changes to its title IV–D program.
If a tribe or tribal organization intends
Total
number of
respondents
Instrument
lotter on DSK11XQN23PROD with NOTICES1
45 CFR part 309—Plan Amendment—Charging fees and recovering costs ..
Comments: The Department
specifically requests comments on (a)
whether the proposed 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
VerDate Sep<11>2014
16:55 Oct 12, 2023
Jkt 262001
to make any substantial or material
changes, a tribal IV–D plan amendment
must be submitted for approval. Tribes
and tribal organizations must have an
approved plan and submit any required
plan amendments to receive funding to
operate a tribal IV–D program.
With this request to revise an
approved information collection, OCSS
proposes a new requirement for tribes
and tribal organizations to provide that
charging fees and recovering costs will
not be permitted. This is due to the
Elimination of the Non-Federal Share
notice of proposed rulemaking
published on April 21, 2023 (see 88 FR
24526). Tribes and tribal organizations
that charge fees and recover costs must
submit a plan amendment
demonstrating compliance with the
proposed new requirement, in
accordance with 45 CFR 309.35(d). This
notice invites comments on this
proposed change and the related burden
implications. This would be a onetime
submission that would be implemented
in conjunction with the issuing of a
Final Rule. Only three tribal child
support programs report data on the
collection of fees and recovered costs.
Respondents: Tribes and tribal
Organizations.
Burden Estimates
The following burden estimates are
specific to burden associated with the
proposed change in requirement. For
information about currently approved
burden under OMB #: 0970–0218,
which is not expected to change, see
information here: https://
www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=202212-0970-012.
Number of
responses per
respondent
3
Average
burden hours
per response
1
Total
burden hours
3
to comments and suggestions submitted
within 60 days of this publication.
Authority: Title IV–D of the Social
Security Act; 45 CFR part 309.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
[Docket No. FDA–2023–N–1189]
[FR Doc. 2023–22630 Filed 10–12–23; 8:45 am]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Importation of
Prescription Drugs
BILLING CODE 4184–41–P
PO 00000
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Fmt 4703
Sfmt 4703
9
E:\FR\FM\13OCN1.SGM
Notice.
13OCN1
70994
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
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 November
13, 2023.
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 0910–0888. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, 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:
Importation of Prescription Drugs
OMB Control Number 0910–0888—
Extension
This information collection supports
implementation of section 804 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 384), and
applicable regulations in part 251 (21
CFR part 251), which provide for the
importation of certain prescription
drugs shipped from Canada. The
purpose of section 804 of the FD&C Act
is to reduce the cost of covered products
to American consumers without
imposing additional risk to public
health and safety. The regulations in
part 251 set forth procedures Section
804 Importation Program sponsors (SIP
Sponsors) must follow when submitting
plans to implement time-limited
programs to begin importation of drugs
from Canada. The regulations also
establish criteria for FDA review and
authorization of a SIP proposal or
supplemental proposal. Additionally,
the regulations set forth requirements
for eligible prescription drugs and
requirements for entities that engage in
importation of eligible prescription
drugs. Finally, the regulations provide
that eligible prescription drugs that
meet certain requirements are exempt
from section 502(f)(1) of the FD&C Act
(21 U.S.C. 352(f)(1)).
Description of Respondents:
Respondents to the collection of
information are SIP Sponsors (States or
Indian Tribes, or in certain future
circumstances, pharmacists or
wholesale distributors, and any
cosponsor(s)), importers (pharmacists or
wholesaler distributors), and
manufacturers of eligible prescription
drugs.
In the Federal Register of June 8, 2023
(88 FR 37549), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
We received one comment
communicating that we had revised our
burden estimates from those found in
the final rule that issued October 1,
2020 (85 FR 62094). The comment also
suggested that our figures
underestimated burden associated with
individual provisions established by
part 251 although no alternative figures
were proffered. We note also, that both
FDA and respondents continue to carry
out certain provisions in part 251,
including activities related to the
information collection elements. The
comment also appeared to question how
FDA derived its count of respondents
included in the information collection.
In this regard, we note that the scope of
the information collection is set forth in
§ 251.1. We appreciate all comments but
refrain from making further
modifications to our estimate until we
have more experience with the
implementation of the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR section 251; information collection activity
Total annual
records
Average
burden per
record
(hours)
Total hours
Subpart B; SIP proposals and pre-import requests ............
Subpart C; Certain requirements for importation programs
40
40
1.5
1
60
40
72
43
4,320
1,720
Total ..............................................................................
........................
........................
100
........................
6,040
1 There
lotter on DSK11XQN23PROD with NOTICES1
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
We assume burden attributable to the
information collection tasks will be
averaged and distributed among
respondents. As noted in the previous
submission, FDA estimates that there
will be 10 SIP Sponsors requiring 360
hours each to research, prepare, and
administer requirements annually; 10
Pre-Import Requests requiring 24 hours
each annually; and 20 manufacturers
also requiring 24 hours each annually to
participate in the program. In addition,
FDA estimates that a recordkeeping
burden of 52 hours will be imposed
annually on the 10 SIP Sponsors, and a
recordkeeping burden of 24 hours will
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16:55 Oct 12, 2023
Jkt 262001
be imposed annually on each of the 10
Importers and the 20 manufacturers.
The 20 manufacturers anticipated to
participate in the program will also
incur an estimated burden of 24 hours
each for copying and providing records
to SIP Sponsors and Importers of foreign
transactions.
We have established a web page at
https://www.fda.gov/about-fda/reports/
importation-program-under-section-804fdc-act to communicate news and
information about FDA efforts to
implement the Section 804 Importation
Program. To date, no SIP proposals have
been authorized since publication of the
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
final rule on October 1, 2020. We have
therefore retained figures from the
previous information collection
approval. We assume burden
attributable to the required retention,
reporting and disclosure of records
pertaining to these information
collection activities will be distributed
among respondents for an average of
100 responses and 6,040 hours
annually.
E:\FR\FM\13OCN1.SGM
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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2023–22653 Filed 10–12–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4066]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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,
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 FDA Recall
Regulations.
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by
December 12, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 12, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
DATES:
lotter on DSK11XQN23PROD with NOTICES1
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
16:55 Oct 12, 2023
Jkt 262001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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–
2023–N–4066 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; FDA
Recall Regulations.’’ 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
PO 00000
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70995
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
‘‘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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
E:\FR\FM\13OCN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70993-70995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22653]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1189]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Importation of
Prescription Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 70994]]
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 November 13, 2023.
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 0910-0888. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Importation of Prescription Drugs
OMB Control Number 0910-0888--Extension
This information collection supports implementation of section 804
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384),
and applicable regulations in part 251 (21 CFR part 251), which provide
for the importation of certain prescription drugs shipped from Canada.
The purpose of section 804 of the FD&C Act is to reduce the cost of
covered products to American consumers without imposing additional risk
to public health and safety. The regulations in part 251 set forth
procedures Section 804 Importation Program sponsors (SIP Sponsors) must
follow when submitting plans to implement time-limited programs to
begin importation of drugs from Canada. The regulations also establish
criteria for FDA review and authorization of a SIP proposal or
supplemental proposal. Additionally, the regulations set forth
requirements for eligible prescription drugs and requirements for
entities that engage in importation of eligible prescription drugs.
Finally, the regulations provide that eligible prescription drugs that
meet certain requirements are exempt from section 502(f)(1) of the FD&C
Act (21 U.S.C. 352(f)(1)).
Description of Respondents: Respondents to the collection of
information are SIP Sponsors (States or Indian Tribes, or in certain
future circumstances, pharmacists or wholesale distributors, and any
cosponsor(s)), importers (pharmacists or wholesaler distributors), and
manufacturers of eligible prescription drugs.
In the Federal Register of June 8, 2023 (88 FR 37549), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment communicating that
we had revised our burden estimates from those found in the final rule
that issued October 1, 2020 (85 FR 62094). The comment also suggested
that our figures underestimated burden associated with individual
provisions established by part 251 although no alternative figures were
proffered. We note also, that both FDA and respondents continue to
carry out certain provisions in part 251, including activities related
to the information collection elements. The comment also appeared to
question how FDA derived its count of respondents included in the
information collection. In this regard, we note that the scope of the
information collection is set forth in Sec. 251.1. We appreciate all
comments but refrain from making further modifications to our estimate
until we have more experience with the implementation of the
information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section 251; information Number of records per Total annual per record Total hours
collection activity respondents recordkeeper records (hours)
----------------------------------------------------------------------------------------------------------------
Subpart B; SIP proposals and pre- 40 1.5 60 72 4,320
import requests................
Subpart C; Certain requirements 40 1 40 43 1,720
for importation programs.......
-------------------------------------------------------------------------------
Total....................... .............. .............. 100 .............. 6,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We assume burden attributable to the information collection tasks
will be averaged and distributed among respondents. As noted in the
previous submission, FDA estimates that there will be 10 SIP Sponsors
requiring 360 hours each to research, prepare, and administer
requirements annually; 10 Pre-Import Requests requiring 24 hours each
annually; and 20 manufacturers also requiring 24 hours each annually to
participate in the program. In addition, FDA estimates that a
recordkeeping burden of 52 hours will be imposed annually on the 10 SIP
Sponsors, and a recordkeeping burden of 24 hours will be imposed
annually on each of the 10 Importers and the 20 manufacturers. The 20
manufacturers anticipated to participate in the program will also incur
an estimated burden of 24 hours each for copying and providing records
to SIP Sponsors and Importers of foreign transactions.
We have established a web page at https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act to communicate
news and information about FDA efforts to implement the Section 804
Importation Program. To date, no SIP proposals have been authorized
since publication of the final rule on October 1, 2020. We have
therefore retained figures from the previous information collection
approval. We assume burden attributable to the required retention,
reporting and disclosure of records pertaining to these information
collection activities will be distributed among respondents for an
average of 100 responses and 6,040 hours annually.
[[Page 70995]]
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22653 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P
