Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 65211-65212 [2022-23510]
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Federal Register / Vol. 87, No. 208 / Friday, October 28, 2022 / Notices
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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–
2022–D–1261 for ‘‘Clostridioides
difficile Infection: Developing Drugs for
Treatment, Reduction of Recurrence,
and Prevention.’’ 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
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
‘‘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://
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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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ramya Gopinath, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6154,
Silver Spring, MD 20993, 240–402–
5328.
65211
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information relating to regulations
found in 21 CFR parts 58, 312, 314, and
601 have been approved under OMB
control numbers 0910–0119, 0910–0014,
0910–0001, and 0910–0338,
respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23457 Filed 10–27–22; 8:45 am]
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clostridioides difficile Infection:
Developing Drugs for Treatment,
Reduction of Recurrence, and
Prevention.’’ The purpose of this draft
guidance is to assist sponsors in the
clinical development of drugs for
treatment, reduction of recurrence, or
prevention of CDI. Specifically, this
guidance addresses FDA’s current
thinking regarding clinical trial design
considerations such as trial populations
and efficacy endpoints for treatment of
CDI, reduction of recurrence, and
prevention.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Clostridioides difficile Infection:
Developing Drugs for Treatment,
Reduction of Recurrence, and
Prevention.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
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Food and Drug Administration
[Docket Nos. FDA–2013–N–0370; FDA–
2011–D–0893; and FDA–2013–N–0093]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
SUMMARY:
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Federal Register / Vol. 87, No. 208 / Friday, October 28, 2022 / Notices
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Infant Formula Requirements ..................................................................................................................................
Export of Medical Devices; Foreign Letters of Approval .........................................................................................
Center for Devices and Radiological Health Appeals Processes ...........................................................................
Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs ..................................
Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23510 Filed 10–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Enrollment and ReCertification of Covered Entities in the
340B Drug Pricing Program, OMB
Number 0915–0327—Revision.
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than November 28,
2022.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
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ADDRESSES:
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To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the Acting HRSA
Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
(301) 443–9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Covered Entities in the 340B Drug
Pricing Program, OMB No. 0915–0327—
Revision.
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted section 340B of the
Public Health Service (PHS) Act, which
instructs HHS to enter into a
Pharmaceutical Pricing Agreement
(PPA) with manufacturers of covered
outpatient drugs. Manufacturers are
required by section 1927(a)(5)(A) of the
Social Security Act to enter into
agreements with the Secretary of HHS
(Secretary) that comply with section
340B of the PHS Act if they participate
in the Medicaid Drug Rebate Program.
When a drug manufacturer signs a PPA,
it is opting into the 340B Drug Pricing
Program (340B Program), and it agrees
to the statutory requirement that prices
charged for covered outpatient drugs to
covered entities will not exceed
statutorily defined 340B ceiling prices.
When an eligible covered entity
voluntarily decides to enroll and
participate in the 340B Program, it
accepts responsibility for ensuring
compliance with all provisions of the
340B Program, including all associated
costs. Covered entities that choose to
participate in the 340B Program must
comply with the requirements of section
340B(a)(5) of the PHS Act. Section
340B(a)(5)(A) of the PHS Act prohibits
a covered entity from accepting a
discount for a drug that would also
generate a Medicaid rebate. Further,
section 340B(a)(5)(B) of the PHS Act
prohibits a covered entity from reselling
or otherwise transferring a discounted
drug to a person who is not a patient of
the covered entity. A 60-day notice was
FOR FURTHER INFORMATION CONTACT:
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0910–0256
0910–0264
0910–0738
0910–0746
Date
approval
expires
3/31/2023
10/31/2025
10/31/2025
10/31/2025
published in the Federal Register on
June 14, 2022, vol. 87, No. 114; pp.
35983–85. There were five comments.
Some comments addressed policy issues
that are outside the scope of this
information collection request. HRSA
responded to technical comments that
pertained to the ICR and revised the
draft instruments based on the
comments received.
Need and Proposed Use of the
Information: To ensure the ongoing
responsibility to administer the 340B
Program while maintaining efficiency,
transparency and integrity, HRSA
developed a process of registration for
covered entities to enable it to address
specific statutory mandates.
Specifically, section 340B(a)(9) of the
PHS Act requires HRSA to notify
manufacturers of the identities of
covered entities and of their status
pertaining to certification and annual
recertification in the 340B Program
pursuant to section 340B(a)(7) and the
establishment of a mechanism to
prevent duplicate discounts as outlined
at section 340B(a)(5)(A)(ii) of the PHS
Act.
In addition, section 340B(a)(1) of the
PHS Act requires each participating
manufacturer to enter into an agreement
with the Secretary in order to offer
covered outpatient drugs to 340B
covered entities.
Finally, section 340B(d)(1)(B)(i) of the
PHS Act requires the development of a
system to enable the Secretary to verify
the accuracy of ceiling prices calculated
by manufacturers under subsection
(a)(1) and charged to covered entities.
HRSA is requesting approval for
existing information collections. HRSA
notes that the previously approved
collections are mostly unchanged,
except several forms have been revised
to increase program efficiency and
integrity. Below are descriptions of each
of the forms and revisions that are
captured in both the registration and
pricing component of the 340B Office of
Pharmacy Affairs Information System
(OPAIS).
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[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65211-65212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0370; FDA-2011-D-0893; and FDA-2013-N-0093]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information
[[Page 65212]]
collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Infant Formula Requirements............. 0910-0256 3/31/2023
Export of Medical Devices; Foreign 0910-0264 10/31/2025
Letters of Approval....................
Center for Devices and Radiological 0910-0738 10/31/2025
Health Appeals Processes...............
Review Transparency & Communication for 0910-0746 10/31/2025
New Molecular Entity NDAs & Original
BLAs...................................
------------------------------------------------------------------------
Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23510 Filed 10-27-22; 8:45 am]
BILLING CODE 4164-01-P
