Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 59622-59623 [2017-27049]
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Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10571]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
February 13, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
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SUMMARY:
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proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10571 Limited Wraparound
Coverage Reporting
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection of information
request; Title of Information Collection:
Limited Wraparound Coverage
Reporting; Use: The Department of
Treasury, the Department of Labor and
the Department of Health and Human
Services published final regulations on
March 18, 2015 (80 FR 13995),
amending the regulations regarding
excepted benefits under the Employee
Retirement Income Security Act of 1974,
the Internal Revenue Code, and the
Public Health Service Act to specify
requirements for limited wraparound
coverage to qualify as an excepted
benefit. The final regulations include
requirements that limited wraparound
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coverage must satisfy in order to qualify
as excepted benefits. One of them is a
reporting requirement, for group health
plans and group health insurance
issuers, as well as group health plan
sponsors.
A self-insured group health plan, or a
health insurance issuer offering or
proposing to offer Multi-State Plan
wraparound coverage, is required to
report to OPM information reasonably
required to determine whether the plan
or issuer qualifies to offer such coverage
or complies with the applicable
requirements. In addition, the plan
sponsor of any group health plan
offering any type of limited wraparound
coverage is required to report to the
Department of Health and Human
Services (HHS), in a form and manner
specified in guidance by the Secretary of
HHS.
We seek comment on the content of
the proposed collection form. We also
seek comment on the impact that an
extension of the limited wraparound
pilot program would have on the
number of employers/sponsors
participating in the limited wraparound
pilot program. In addition, if HHS
extends the limited wraparound pilot
program, we seek comment on when the
limited wraparound pilot program
should sunset, or whether the limited
wraparound pilot program should be
made permanent. Form Number: CMS–
10571 (OMB control number: 0938–
NEW); Frequency: Once; Affected
Public: Private Sector; Number of
Respondents: 8; Number of Responses:
8; Total Annual Hours: 24. (For policy
questions regarding this collection
contact Usree Bandyopadhyay at 410–
786–6650).
Dated: December 12, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–27048 Filed 12–14–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0809]
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
SUMMARY:
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Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the 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 MEPSEVII
(vestronidase alfa-vjbk), manufactured
by Ultragenyx Pharmaceutical, 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.
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 MEPSEVII
(vestronidase alfa-vjbk), manufactured
by Ultragenyx Pharmaceutical, Inc.,
meets the criteria for a priority review
voucher. MEPSEVII (vestronidase alfavjbk) is indicated for the treatment of
Mucopolysaccharidosis type VII (MPS
VII, Sly Syndrome).
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/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about MEPSEVII
(vestronidase alfa-vjbk), go to the
‘‘Drugs@FDA’’ website at https://www.
accessdata.fda.gov/scripts/cder/daf/.
SUPPLEMENTARY INFORMATION:
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Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27049 Filed 12–14–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6702]
The Least Burdensome Provisions:
Concept and Principles; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘The Least
Burdensome Provisions: Concept and
Principles’’ FDA utilizes a least
burdensome approach to medical device
regulation to eliminate unnecessary
burdens that may delay the marketing of
beneficial new products, while
maintaining the statutory requirements
for clearance and approval. This
document describes the guiding
principles and recommended approach
for FDA staff and industry to facilitate
consistent application of least
burdensome principles to the activities
pertaining to products meeting the
statutory definition of a device regulated
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by February 13, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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
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
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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’’).
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–
2017–D–6702 for ‘‘The Least
Burdensome Provisions: Concept and
Principles; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability.’’ 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.
• 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
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]]>Agencies
[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59622-59623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
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
[[Page 59623]]
the sponsor of a rare pediatric disease product application. The
Federal Food, Drug, and Cosmetic Act (the 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 MEPSEVII (vestronidase
alfa-vjbk), manufactured by Ultragenyx Pharmaceutical, 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
MEPSEVII (vestronidase alfa-vjbk), manufactured by Ultragenyx
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
MEPSEVII (vestronidase alfa-vjbk) is indicated for the treatment of
Mucopolysaccharidosis type VII (MPS VII, Sly Syndrome).
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 MEPSEVII (vestronidase alfa-vjbk), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27049 Filed 12-14-17; 8:45 am]
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