Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 14130 [2021-05208]
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14130
Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR section
Number of
records per
recordkeeper 2
Average
burden per
recordkeeping
Total annual
records
Total hours
Subpart C: Sales Restrictions
203.23(a) and (b); returns ..............................................
203.23(c); documentation of storage of returns .............
2,200
2,200
71.9909
71.9909
158,380
158,380
.25 (15 minutes)
.08 (6 minutes) ...
39,595
12,670
Subpart D: Samples
203.30–203.39; documentation regarding sample distributions.
140
202
28,280
Total .........................................................................
........................
........................
345,040
1 There
∼.07–.08 (∼4–5
minutes).
.............................
2,121
54,386
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
Based on a review of Agency data, we
assume 2,200 respondents may incur
burden resulting from the information
collection activity associated with the
requirements in § 203.23(a) through (c).
One hundred and forty pharmaceutical
companies have submitted information
to the Agency on drug sample
distribution under part 203. Those same
respondents also have recordkeeping
requirements under part 203. Our
estimate of the burden of the average
burden per recordkeeping reflects a
cumulative average to cover all
applicable requirements. Since our last
request for OMB approval, we have
adjusted our estimate of the overall
burden downward to reflect a decrease
of 2,567,713 hours and 64,432,232
records annually. We attribute this
adjustment to a more accurate reflection
of the number of respondents to the
information collection and clarification
that burden attributable to requirements
of the Drug Quality and Security Act are
not included in this information
collection.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05214 Filed 3–11–21; 8:45 am]
BILLING CODE 4164–01–P
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.
VerDate Sep<11>2014
17:04 Mar 11, 2021
Jkt 253001
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 AMONDYS 45
(casimersen), manufactured by Sarepta
Therapeutics Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
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 AMONDYS 45
(casimersen) manufactured by Sarepta
Therapeutics Inc., meets the criteria for
a priority review voucher. AMONDYS
45 (casimersen) is indicated for the
treatment of Duchenne Muscular
Dystrophy (DMD) in patients who have
a confirmed mutation of the DMD gene
that is amenable to exon 45 skipping.
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/
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about AMONDYS
45 (casimersen), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05208 Filed 3–11–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2197]
VistaPharm, Inc., et.al.; Withdrawal of
Approval of 10 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on December 11, 2020. The
document announced the withdrawal of
approval (as of January 11, 2021) of 10
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
two ANDAs after receiving a withdrawal
request from VistaPharm, Inc., 7265
Ulmerton Rd., Largo, FL 33771: ANDA
040323, Prednisolone Syrup, 15
milligrams (mg)/5 milliliters (mL); and
ANDA 075782, Valproic Acid Syrup,
250 mg/5 mL. Before FDA withdrew the
approval of these ANDAs, VistaPharm,
Inc., informed FDA that it did not want
SUMMARY:
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Page 14130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05208]
-----------------------------------------------------------------------
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 AMONDYS 45 (casimersen), manufactured by Sarepta Therapeutics
Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, email: [email protected].
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
AMONDYS 45 (casimersen) manufactured by Sarepta Therapeutics Inc.,
meets the criteria for a priority review voucher. AMONDYS 45
(casimersen) is indicated for the treatment of Duchenne Muscular
Dystrophy (DMD) in patients who have a confirmed mutation of the DMD
gene that is amenable to exon 45 skipping.
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 AMONDYS 45 (casimersen), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05208 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P
