80 FR 71811 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 221 (November 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 221 (November 17, 2015)
| Page Range | 71811-71812 | |
| FR Document | 2015-29280 |
[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)] [Notices] [Pages 71811-71812] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://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
![Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices 71811
inflammatory drugs. It went into effect the regulation. To address this potential DEPARTMENT OF HEALTH AND
April 29, 2010. confusion, the Agency does not intend HUMAN SERVICES
Under that rule, the labeling for OTC to object to the inclusion of a liver
IAAA products that contain warning that differs from that required Food and Drug Administration
acetaminophen and are labeled for under § 201.326(a)(1)(iii)(A) and [Docket No. FDA–2014–N–0229]
adults only must include the liver § 201.326(a)(1)(v)(A), provided the
warning described below. Similarly, the warning appears as described in the Issuance of Priority Review Voucher;
labeling for OTC IAAA products that guidance. Rare Pediatric Disease Product
contain acetaminophen and are labeled
In the Federal Register of July 5, 2012 AGENCY: Food and Drug Administration,
for adults and children under 12 year of
(77 FR 39710), FDA published a draft HHS.
age must include a similar liver warning
guidance entitled ‘‘Organ-Specific ACTION: Notice.
described below.
Adults Only (§ 201.326(a)(1)(iii)(A) Warnings: Internal Analgesic,
(21 CFR 201.326(a)(1)(iii)(A))): Antipyretic, and Antirheumatic Drug SUMMARY: The Food and Drug
Products for Over-the-Counter Human Administration (FDA) is announcing the
Liver warning: This product contains Use—Labeling for Products That issuance of a priority review voucher to
acetaminophen. Severe liver damage may
Contain Acetaminophen.’’ The July the sponsor of a rare pediatric disease
occur if you take • more than [insert
maximum number of daily dosage units] in 2012 draft guidance gave interested product application. The Federal Food,
24 hours, which is the maximum daily persons an opportunity to submit Drug, and Cosmetic Act (the FD&C Act),
amount [optional: ‘‘for this product’’] • with comments through September 4, 2012. as amended by the Food and Drug
other drugs containing acetaminophen • 3 or We have made changes to the guidance Administration Safety and Innovation
more alcoholic drinks every day while using in response to comments received and Act (FDASIA), authorizes FDA to award
this product. have clarified the information in section priority review vouchers to sponsors of
Adults and children under 12 years of III of the draft guidance. rare pediatric disease product
age (§ 201.326(a)(1)(v)(A) (21 CFR This guidance is being issued applications that meet certain criteria.
201.326(a)(1)(v)(A))): consistent with FDA’s good guidance FDA has determined that STRENSIQ
Liver warning: This product contains (asfotase alfa), manufactured by Alexion
practices regulation (21 CFR 10.115).
acetaminophen. Severe liver damage may Pharmaceuticals, Inc., meets the criteria
The guidance represents the current
occur if • adult takes more than [insert thinking of FDA on Organ-Specific
for a priority review voucher.
maximum number of daily dosage units] in FOR FURTHER INFORMATION CONTACT:
24 hours, which is the maximum daily Warnings: Internal Analgesic,
Antipyretic, and Antirheumatic Drug Larry Bauer, Rare Diseases Program,
amount [optional: ‘‘for this product’’] • child Center for Drug Evaluation and
takes more than 5 doses in 24 hours • taken Products for Over-the-Counter Human
with other drugs containing acetaminophen Use—Labeling for Products That Research, Food and Drug
• adult has 3 or more alcoholic drinks every Contain Acetaminophen. It does not Administration, 10903 New Hampshire
day while using this product. establish any rights for any person and Ave., Bldg. 22, Rm. 6408, Silver Spring,
Although the currently proposed is not binding on FDA or the public. MD 20993–0002, 301–796–4842, FAX:
maximum daily dose of acetaminophen 301–796–9858, email: larry.bauer@
You can use an alternative approach if
is 4,000 milligrams (mg), some OTC fda.hhs.gov.
it satisfies the requirements of the
IAAA products that contain applicable statutes and regulations. SUPPLEMENTARY INFORMATION: FDA is
acetaminophen have directions for use announcing the issuance of a priority
that provide a maximum daily dose of II. Paperwork Reduction Act of 1965 review voucher to the sponsor of a rare
acetaminophen for that product that is The recommendations in this pediatric disease product application.
less than 4,000 mg. For example, for guidance are not subject to review by Under section 529 of the FD&C Act (21
some OTC IAAA drug products that the Office of Management and Budget U.S.C. 360ff), which was added by
contain both acetaminophen and one or FDASIA, FDA will award priority
because they do not constitute a
more other active ingredients, the review vouchers to sponsors of rare
‘‘collection of information’’ under the
maximum number of daily dosage units pediatric disease product applications
Paperwork Reduction Act of 1995 (44
might be limited by an active ingredient that meet certain criteria. FDA has
U.S.C. 3501 et seq.). Rather, the labeling
other than acetaminophen, which could determined that STRENSIQ (asfotase
statements are a ‘‘public disclosure of
result in a maximum daily dose of alfa), manufactured by Alexion
acetaminophen that is less than 4,000 information originally supplied by the Pharmaceuticals, Inc., meets the criteria
mg for that product. The optional Federal government to the recipient for for a priority review voucher. Asfotase
statement, ‘‘for this product,’’ in the first the purpose of disclosure to the public’’ alfa is a long-term enzyme replacement
bullet of the liver warning is intended (5 CFR 1320.3(c)(2)). therapy for patients with infantile- and
to address these situations by clarifying III. Electronic Access juvenile-onset hypophosphatasia (HPP).
that the maximum number of daily HPP is a rare genetic disorder that
dosage units for a product might not Persons with access to the Internet affects the development of bones and
reflect the maximum daily dose of may obtain the document at either teeth.
acetaminophen. http://www.fda.gov/Drugs/Guidance For further information about the Rare
However, the Agency understands ComplianceRegulatoryInformation/ Pediatric Disease Priority Review
mstockstill on DSK4VPTVN1PROD with NOTICES
that in certain circumstances, despite Guidances/default.htm or http:// Voucher Program and for a link to the
this optional statement, the wording of www.regulations.gov. full text of section 529 of the FD&C Act,
the first bullet in the warnings shown Dated: November 12, 2015. go to http://www.fda.gov/ForIndustry/
above might be interpreted as indicating DevelopingProductsforRareDiseases
Leslie Kux,
that severe liver damage is associated Conditions/RarePediatricDiseasePriority
with a total daily dose of Associate Commissioner for Policy. VoucherProgram/default.htm.
acetaminophen that is less than 4,000 [FR Doc. 2015–29281 Filed 11–16–15; 8:45 am] For further information about
mg. This suggestion is not the intent of BILLING CODE 4164–01–P STRENSIQ (asfotase alfa), go to the
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![71812 Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
Drugs@FDA Web site at http://www. on Labor and Human Resources of the committees is fairly balanced in terms of
accessdata.fda.gov/scripts/cder/drugsat Senate, and the Committee on points of view represented and the
fda/index.cfm. Commerce of the House of committee’s function. Every effort is
Dated: November 9, 2015. Representatives, a report describing the made to ensure that the views of
Leslie Kux,
activities of the council, including women, all ethnic and racial groups,
findings and recommendations made by and people with disabilities are
Associate Commissioner for Policy.
the NACNEP concerning the activities represented on HHS Federal advisory
[FR Doc. 2015–29280 Filed 11–16–15; 8:45 am]
under Title VIII. committees. The Department also
BILLING CODE 4164–01–P Specifically, HRSA is requesting encourages geographic diversity in the
nominations for voting members of the composition of the committee. The
NACNEP representing leading Department encourages nominations of
DEPARTMENT OF HEALTH AND authorities in the various fields of
HUMAN SERVICES qualified candidates from all groups and
nursing, higher and secondary locations. Appointment to the NACNEP
Health Resources and Services education, and associate degree schools shall be made without discrimination
Administration of nursing; and from representatives of on the basis of age, race, ethnicity,
advanced education nursing groups gender, sexual orientation, disability,
National Advisory Council on Nurse (such as nurse practitioners, nurse and cultural, religious, or
Education and Practice; Notice for midwives, and nurse anesthetists); from socioeconomic status.
Request for Nominations hospitals and other institutions and
organizations which provide nursing Jackie Painter,
SUMMARY: The Health Resources and services; from practicing professional Director, Division of the Executive Secretariat.
Services Administration (HRSA) is nurses; from the general public; and [FR Doc. 2015–29195 Filed 11–16–15; 8:45 am]
requesting nominations to fill vacancies full-time students enrolled in schools of BILLING CODE 4165–15–P
on the National Advisory Council on nursing. The majority of NACNEP
Nurse Education and Practice members shall be nurses.
(NACNEP). The NACNEP is in The Department of Health and Human DEPARTMENT OF HEALTH AND
accordance with the provisions of 42 Services (HHS) will consider HUMAN SERVICES
United States Code (U.S.C.) 297t; nominations of all qualified individuals
Section 851 of the Public Health Service with the areas of subject matter Health Resources and Services
Act, as amended. The Council is expertise noted above. Individuals may Administration
governed by provisions of Public Law nominate themselves or other
92–463, which sets forth standards for individuals, and professional National Advisory Council on Migrant
the formation and use of advisory associations and organizations may Health Request for Nominations for
committees. nominate one or more qualified persons Voting Members
DATES: The agency will receive for membership. Nominations shall state AGENCY: Health Resources and Services
nominations on a continuous basis. that the nominee is willing to serve as Administration, HHS.
a member of the NACNEP and appears ACTION: Notice.
ADDRESSES: All nominations should be
to have no conflict of interest that
submitted to Regina Wilson, Advisory
would preclude the NACNEP SUMMARY: The Health Resources and
Council Operations, Bureau of Health
membership. Potential candidates will Services Administration (HRSA) is
Workforce, HRSA, 11w45c, 5600 Fishers
be asked to provide detailed information requesting nominations to fill vacancies
Lane, Rockville, Maryland 20857. Mail
concerning financial interests, on the National Advisory Council on
delivery should be addressed to Regina
consultancies, research grants, and/or Migrant (NACMH). The NACMH is
Wilson, Advisory Council Operations,
contracts that might be affected by authorized under 42 U.S.C. 218, section
Bureau of Health Workforce, HRSA, at
recommendations of the NACNEP to 217 of the Public Health Service (PHS)
the above address, or via email to: permit evaluation of possible sources of
RWilson@hrsa.gov. Act, as amended and governed by
conflicts of interest. provisions of Public Law 92–463, as
FOR FURTHER INFORMATION CONTACT: Erin A nomination package should include amended, (5 U.S.C. Appendix 2).
Fowler, Designated Federal Official, the following information for each DATES: The agency will receive
NACNEP, by phone at 301–443–7308 or nominee: (1) A letter of nomination
by email at efowler@hrsa.gov. A copy of nominations on a continuous basis.
stating the name, affiliation, and contact
the current committee membership, ADDRESSES: All nominations should be
information for the nominee, the basis
charter and reports can be obtained by addressed to the Designated Federal
for the nomination (i.e., what specific
accessing the NACNEP Web site. Official, NACMH, Strategic Initiatives
attributes, perspectives, and/or skills
SUPPLEMENTARY INFORMATION: Under the
and Planning Division, Office of Policy
does the individual possess that would
authorities that established the NACNEP and Program Development, Bureau of
benefit the workings of NACNEP), and
and the Federal Advisory Committee Primary Health Care, HRSA, Suite 17C–
the nominee’s field(s) of expertise; (2) a
Act, HRSA is requesting nominations 05, 5600 Fishers Lane, Rockville,
biographical sketch of the nominee and
for new committee members. The Maryland 20857 or via email to:
a copy of his/her curriculum vitae; and
NACNEP provides advice and JRodrigue@hrsa.gov and GCate@
(3) the name, address, daytime
recommendations to the Secretary and hrsa.gov.
telephone number, and email address at
FOR FURTHER INFORMATION CONTACT: CDR
mstockstill on DSK4VPTVN1PROD with NOTICES
Congress in preparation of general which the nominator can be contacted.
regulations and concerning policy Nominations will be considered as Jacqueline Rodrigue, MSW, Designated
matters arising in the administration of vacancies occur on the NACNEP. Federal Official, NACMH, at (301) 443–
Title VIII, including the range of issues Nominations should be updated and 1127 or email JRodrigue@hrsa.gov.
relating to the nurse workforce, resubmitted every 3 years to continue to SUPPLEMENTARY INFORMATION: As
education, and practice improvement. be considered for committee vacancies. authorized under section 330(g) of the
Annually, the NACNEP prepares and HHS strives to ensure that the Public Health Service Act, as amended,
submits to the Secretary, the Committee membership of HHS Federal advisory 42 U.S.C. 254b, the Secretary
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Document Created: 2015-12-14 14:01:09
Document Modified: 2015-12-14 14:01:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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: [email protected] | |
| FR Citation | 80 FR 71811 |
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