Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 71811-71812 [2015-29280]
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Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
inflammatory drugs. It went into effect
April 29, 2010.
Under that rule, the labeling for OTC
IAAA products that contain
acetaminophen and are labeled for
adults only must include the liver
warning described below. Similarly, the
labeling for OTC IAAA products that
contain acetaminophen and are labeled
for adults and children under 12 year of
age must include a similar liver warning
described below.
Adults Only (§ 201.326(a)(1)(iii)(A)
(21 CFR 201.326(a)(1)(iii)(A))):
Liver warning: This product contains
acetaminophen. Severe liver damage may
occur if you take • more than [insert
maximum number of daily dosage units] in
24 hours, which is the maximum daily
amount [optional: ‘‘for this product’’] • with
other drugs containing acetaminophen • 3 or
more alcoholic drinks every day while using
this product.
Adults and children under 12 years of
age (§ 201.326(a)(1)(v)(A) (21 CFR
201.326(a)(1)(v)(A))):
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Liver warning: This product contains
acetaminophen. Severe liver damage may
occur if • adult takes more than [insert
maximum number of daily dosage units] in
24 hours, which is the maximum daily
amount [optional: ‘‘for this product’’] • child
takes more than 5 doses in 24 hours • taken
with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every
day while using this product.
Although the currently proposed
maximum daily dose of acetaminophen
is 4,000 milligrams (mg), some OTC
IAAA products that contain
acetaminophen have directions for use
that provide a maximum daily dose of
acetaminophen for that product that is
less than 4,000 mg. For example, for
some OTC IAAA drug products that
contain both acetaminophen and one or
more other active ingredients, the
maximum number of daily dosage units
might be limited by an active ingredient
other than acetaminophen, which could
result in a maximum daily dose of
acetaminophen that is less than 4,000
mg for that product. The optional
statement, ‘‘for this product,’’ in the first
bullet of the liver warning is intended
to address these situations by clarifying
that the maximum number of daily
dosage units for a product might not
reflect the maximum daily dose of
acetaminophen.
However, the Agency understands
that in certain circumstances, despite
this optional statement, the wording of
the first bullet in the warnings shown
above might be interpreted as indicating
that severe liver damage is associated
with a total daily dose of
acetaminophen that is less than 4,000
mg. This suggestion is not the intent of
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the regulation. To address this potential
confusion, the Agency does not intend
to object to the inclusion of a liver
warning that differs from that required
under § 201.326(a)(1)(iii)(A) and
§ 201.326(a)(1)(v)(A), provided the
warning appears as described in the
guidance.
In the Federal Register of July 5, 2012
(77 FR 39710), FDA published a draft
guidance entitled ‘‘Organ-Specific
Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Labeling for Products That
Contain Acetaminophen.’’ The July
2012 draft guidance gave interested
persons an opportunity to submit
comments through September 4, 2012.
We have made changes to the guidance
in response to comments received and
have clarified the information in section
III of the draft guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on Organ-Specific
Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products for Over-the-Counter Human
Use—Labeling for Products That
Contain Acetaminophen. 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 1965
The recommendations in this
guidance are not subject to review by
the Office of Management and Budget
because they do not constitute a
‘‘collection of information’’ under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.). Rather, the labeling
statements are a ‘‘public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public’’
(5 CFR 1320.3(c)(2)).
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29281 Filed 11–16–15; 8:45 am]
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71811
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
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 (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
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that STRENSIQ
(asfotase alfa), manufactured by Alexion
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6408, Silver Spring,
MD 20993–0002, 301–796–4842, FAX:
301–796–9858, email: larry.bauer@
fda.hhs.gov.
SUMMARY:
FDA is
announcing the issuance of a priority
review voucher to the sponsor of a 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 rare
pediatric disease product applications
that meet certain criteria. FDA has
determined that STRENSIQ (asfotase
alfa), manufactured by Alexion
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. Asfotase
alfa is a long-term enzyme replacement
therapy for patients with infantile- and
juvenile-onset hypophosphatasia (HPP).
HPP is a rare genetic disorder that
affects the development of bones and
teeth.
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
STRENSIQ (asfotase alfa), go to the
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
Drugs@FDA Web site at https://www.
accessdata.fda.gov/scripts/cder/drugsat
fda/index.cfm.
Dated: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29280 Filed 11–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; Notice for
Request for Nominations
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill vacancies
on the National Advisory Council on
Nurse Education and Practice
(NACNEP). The NACNEP is in
accordance with the provisions of 42
United States Code (U.S.C.) 297t;
Section 851 of the Public Health Service
Act, as amended. The Council is
governed by provisions of Public Law
92–463, which sets forth standards for
the formation and use of advisory
committees.
DATES: The agency will receive
nominations on a continuous basis.
ADDRESSES: All nominations should be
submitted to Regina Wilson, Advisory
Council Operations, Bureau of Health
Workforce, HRSA, 11w45c, 5600 Fishers
Lane, Rockville, Maryland 20857. Mail
delivery should be addressed to Regina
Wilson, Advisory Council Operations,
Bureau of Health Workforce, HRSA, at
the above address, or via email to:
RWilson@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Erin
Fowler, Designated Federal Official,
NACNEP, by phone at 301–443–7308 or
by email at efowler@hrsa.gov. A copy of
the current committee membership,
charter and reports can be obtained by
accessing the NACNEP Web site.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the NACNEP
and the Federal Advisory Committee
Act, HRSA is requesting nominations
for new committee members. The
NACNEP provides advice and
recommendations to the Secretary and
Congress in preparation of general
regulations and concerning policy
matters arising in the administration of
Title VIII, including the range of issues
relating to the nurse workforce,
education, and practice improvement.
Annually, the NACNEP prepares and
submits to the Secretary, the Committee
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SUMMARY:
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on Labor and Human Resources of the
Senate, and the Committee on
Commerce of the House of
Representatives, a report describing the
activities of the council, including
findings and recommendations made by
the NACNEP concerning the activities
under Title VIII.
Specifically, HRSA is requesting
nominations for voting members of the
NACNEP representing leading
authorities in the various fields of
nursing, higher and secondary
education, and associate degree schools
of nursing; and from representatives of
advanced education nursing groups
(such as nurse practitioners, nurse
midwives, and nurse anesthetists); from
hospitals and other institutions and
organizations which provide nursing
services; from practicing professional
nurses; from the general public; and
full-time students enrolled in schools of
nursing. The majority of NACNEP
members shall be nurses.
The Department of Health and Human
Services (HHS) will consider
nominations of all qualified individuals
with the areas of subject matter
expertise noted above. Individuals may
nominate themselves or other
individuals, and professional
associations and organizations may
nominate one or more qualified persons
for membership. Nominations shall state
that the nominee is willing to serve as
a member of the NACNEP and appears
to have no conflict of interest that
would preclude the NACNEP
membership. Potential candidates will
be asked to provide detailed information
concerning financial interests,
consultancies, research grants, and/or
contracts that might be affected by
recommendations of the NACNEP to
permit evaluation of possible sources of
conflicts of interest.
A nomination package should include
the following information for each
nominee: (1) A letter of nomination
stating the name, affiliation, and contact
information for the nominee, the basis
for the nomination (i.e., what specific
attributes, perspectives, and/or skills
does the individual possess that would
benefit the workings of NACNEP), and
the nominee’s field(s) of expertise; (2) a
biographical sketch of the nominee and
a copy of his/her curriculum vitae; and
(3) the name, address, daytime
telephone number, and email address at
which the nominator can be contacted.
Nominations will be considered as
vacancies occur on the NACNEP.
Nominations should be updated and
resubmitted every 3 years to continue to
be considered for committee vacancies.
HHS strives to ensure that the
membership of HHS Federal advisory
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committees is fairly balanced in terms of
points of view represented and the
committee’s function. Every effort is
made to ensure that the views of
women, all ethnic and racial groups,
and people with disabilities are
represented on HHS Federal advisory
committees. The Department also
encourages geographic diversity in the
composition of the committee. The
Department encourages nominations of
qualified candidates from all groups and
locations. Appointment to the NACNEP
shall be made without discrimination
on the basis of age, race, ethnicity,
gender, sexual orientation, disability,
and cultural, religious, or
socioeconomic status.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–29195 Filed 11–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health Request for Nominations for
Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill vacancies
on the National Advisory Council on
Migrant (NACMH). The NACMH is
authorized under 42 U.S.C. 218, section
217 of the Public Health Service (PHS)
Act, as amended and governed by
provisions of Public Law 92–463, as
amended, (5 U.S.C. Appendix 2).
DATES: The agency will receive
nominations on a continuous basis.
ADDRESSES: All nominations should be
addressed to the Designated Federal
Official, NACMH, Strategic Initiatives
and Planning Division, Office of Policy
and Program Development, Bureau of
Primary Health Care, HRSA, Suite 17C–
05, 5600 Fishers Lane, Rockville,
Maryland 20857 or via email to:
JRodrigue@hrsa.gov and GCate@
hrsa.gov.
FOR FURTHER INFORMATION CONTACT: CDR
Jacqueline Rodrigue, MSW, Designated
Federal Official, NACMH, at (301) 443–
1127 or email JRodrigue@hrsa.gov.
SUPPLEMENTARY INFORMATION: As
authorized under section 330(g) of the
Public Health Service Act, as amended,
42 U.S.C. 254b, the Secretary
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71811-71812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0229]
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 (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 rare pediatric disease
product applications that meet certain criteria. FDA has determined
that STRENSIQ (asfotase alfa), manufactured by Alexion Pharmaceuticals,
Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6408, Silver Spring, MD 20993-
0002, 301-796-4842, FAX: 301-796-9858, email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of a 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 rare pediatric disease product applications that meet
certain criteria. FDA has determined that STRENSIQ (asfotase alfa),
manufactured by Alexion Pharmaceuticals, Inc., meets the criteria for a
priority review voucher. Asfotase alfa is a long-term enzyme
replacement therapy for patients with infantile- and juvenile-onset
hypophosphatasia (HPP). HPP is a rare genetic disorder that affects the
development of bones and teeth.
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 STRENSIQ (asfotase alfa), go to the
[[Page 71812]]
Drugs@FDA Web site at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Dated: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29280 Filed 11-16-15; 8:45 am]
BILLING CODE 4164-01-P
