Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 16274-16275 [2023-05355]
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
determine whether research studies may
be conducted under an FDA-approved
RDRC, or whether research studies must
be conducted under an investigational
new drug application. It also offers
answers to frequently asked questions
on conducting research with radioactive
drugs, and provides information on the
membership, functions, and reporting
requirements of an RDRC approved by
FDA. All Agency guidance documents
are issued consistent with our good
guidance practice regulations at 21 CFR
10.115.
Under § 361.1(d)(5), each investigator
will obtain the proper consent required
under the regulations. Each female
research subject of childbearing
potential must state in writing that she
is not pregnant or, based on a pregnancy
test, be confirmed as not pregnant.
Under § 361.1(d)(8), the investigator
will immediately report to the RDRC all
adverse effects associated with use of
covered in OMB control number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks. Respondents to
this information collection are the
chairperson or chairpersons of each
individual RDRC, investigators, and
participants in the studies. The burden
estimates are based on our experience
with these reporting and recordkeeping
requirements and the number of
submissions we received under the
regulations over the past 3 years.
We estimate the burden of this
collection of information as follows:
the drug, and the committee will then
report to FDA all adverse reactions
probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
reporting burden estimate because they
are information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Types of research studies not
permitted under the regulations are also
specified and include those intended for
immediate therapeutic, diagnostic, or
similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an
investigational new drug application
under 21 CFR part 312, and the
associated information collections, are
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section and FDA form
Number of
responses per
respondent
Total annual
responses
Average burden
per response
(in hours)
Total hours
§ 361.1(c)(3) reports and (c)(4) approval (Form FDA 2914: Membership
Summary) 2.
§ 361.1(c)(3) reports (Form FDA 2915: Study Summary) 3 .....................
§ 361.1(d)(8) adverse events ...................................................................
56
1
56
1 ..................................
56
37
10
10
1
370
10
3 ..................................
0.5 (30 minutes) .........
1,110
5
Total ..................................................................................................
........................
........................
436
.....................................
1,171
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
3 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Total annual
records
Average burden per
recordkeeping
(in hours)
Total hours
§ 361.1(c)(2) RDRC ..................................................................................
§ 361.1(d)(5) human research subjects ...................................................
56
37
4
10
224
370
10 ................................
0.75 (45 minutes) .......
2,240
278
Total ..................................................................................................
........................
........................
594
.....................................
2,518
1
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our estimate for the
information collection to reflect an
annual decrease of 703 hours and 158
responses since OMB’s last approval.
We attribute this adjustment to a
decrease from 3.5 hours to 3 hours per
response for public reporting burden for
Form FDA–2915: Study Summary to
match the burden hours reflected on the
form. In addition, this adjustment is also
attributable to the Agency receiving
fewer submissions over the last few
years.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05357 Filed 3–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
SUMMARY:
PO 00000
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Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that LAMZEDE
(velmanase alfa-tycv), approved
February 16, 2023, and manufactured by
Chiesi Farmaceutici S.p.A., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that LAMZEDE
(velmanase alfa-tycv), manufactured by
Chiesi Farmaceutici S.p.A., meets the
criteria for a priority review voucher.
LAMZEDE (velmanase alfa-tycv)
injection is for the treatment of noncentral nervous system manifestations
of alpha-mannosidosis.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
LAMZEDE (velmanase alfa-tycv), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05355 Filed 3–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 15, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0473–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.gov, or call (202) 795–7714 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
SUMMARY:
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: HHS Subpart C
Certification Form.
Type of Collection: Revision.
OMB No.: 0990–0473.
Abstract: The Office for Human
Research Protections (OHRP) is
requesting a three-year approval on a
0revision of OMB No. 0990–0473, the
HHS Subpart C Certification Form. The
purpose of this form is to provide a
simplified, standardized procedure for
institutions to submit subpart C research
certifications to OHRP in order to obtain
authorization to include prisoners in
HHS-conducted or supported human
subjects research. The form also
simplifies the internal process used by
OHRP to review and record such
certifications, resulting in faster
processing while reducing unnecessary
and burdensome staff time.
Likely Respondents: Institutions or
Organizations operating Institutional
Review Boards (IRBs) that have enrolled
or are planning to enroll prisoners in
human subjects research conducted or
supported by HHS.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Form name
Average burden
per response
(in hours)
Total burden
hours
Subpart C Certification Form .......................................................................
Subpart C Certification Form .......................................................................
25
5
2
3
1.0
1.0
50
15
Total ......................................................................................................
........................
........................
............................
65
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–05345 Filed 3–15–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Number of
responses per
respondent
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
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meeting of the Sleep Disorders Research
Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sleep Disorders
Research Advisory Board Sleep Disorders
Research Advisory Board.
Date: April 6–7, 2023.
Open: April 06, 2023, 1:00 p.m. to 5:00
p.m.
Agenda: The purpose of this meeting is to
update the Advisory Board and public
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stakeholders on the progress of sleep and
circadian research activities across NIH, and
the activities of Federal stakeholders and
interested organizations.
Place: Virtual-Teleconference, ZoomGov
and In-Person.
Virtual: The event is free and open to the
public, however, registration is required.
Please use this link to register: https://
nih.zoomgov.com/webinar/register/WN_
NjI6hGOLQgmEGTNOe2zTzA.
In Person: Two Rockledge Centre,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20817.
Open: April 07, 2023, 9:00 a.m. to 2:00
p.m.
Agenda: The purpose of this meeting is to
update the Advisory Board and public
stakeholders on the progress of sleep and
circadian research activities across NIH, and
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16274-16275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to award priority
review vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that LAMZEDE (velmanase alfa-tycv), approved February 16, 2023, and
manufactured by Chiesi Farmaceutici S.p.A., meets the criteria for a
priority review voucher.
FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email:
[email protected].
[[Page 16275]]
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
LAMZEDE (velmanase alfa-tycv), manufactured by Chiesi Farmaceutici
S.p.A., meets the criteria for a priority review voucher. LAMZEDE
(velmanase alfa-tycv) injection is for the treatment of non-central
nervous system manifestations of alpha-mannosidosis.
For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about LAMZEDE (velmanase alfa-tycv), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05355 Filed 3-15-23; 8:45 am]
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