18628 Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 

Regency, 1209 L Street, Sacramento, 

California 95814 

• July 30, 2015—Oklahoma Indian Head 

Start Coalition Conference, 

DoubleTree at Warren Place, 6110 

South Yale Avenue, Tulsa, Oklahoma 

74136 

• August 17, 2015—Northwest Indian 

Head Start Association Conference, 

Holiday Inn Grand Montana, 5500 

Midland Road, Billings, Montana 

59101 

FOR FURTHER INFORMATION CONTACT: 

Robert Bialas, Regional Program 

Manager, Region XI, Office of Head 

Start, email Robert.Bialas@acf.hhs.gov 

or phone (202) 205–9497. Additional 

information and online meeting 

registration is available at http://eclkc.

ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces OHS Tribal 

Consultations for leaders of Tribal 

Governments operating Head Start and 

Early Head Start programs. 

The agenda for the scheduled OHS 

Tribal Consultations in Sacramento, 

California, Tulsa, Oklahoma, and 

Billings, Montana, will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of American Indian/ 

Alaska Native children and families, 

taking into consideration funding 

allocations, distribution formulas, and 

other issues affecting the delivery of 

Head Start services in their geographic 

locations. In addition, OHS will share 

actions taken and in progress to address 

the issues and concerns raised in 2014 

OHS Tribal Consultations. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 U.S.C. 

9835, Section 640(l)(4)(A)]. Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe prior to the 

Consultation Sessions. Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of the Consultation 

Sessions will be prepared and made 

available within 45 days of the 

Consultation Sessions to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Robert Bialas at 

Robert.Bialas@acf.hhs.gov either prior 

to the Consultation Sessions or within 

30 days after the meeting. 

OHS will summarize oral testimony 

and comments from each Consultation 

Session in the report without 

attribution, along with topics of concern 

and recommendations. OHS has sent 

hotel and logistical information for the 

California, Oklahoma, and Montana 

Consultation Sessions to tribal leaders 

via email and posted information on the 

Early Childhood Learning and 

Knowledge Center Web site at http://

eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

Dated: March 26, 2015. 

Ann Linehan, 

Acting Director, Office of Head Start. 

[FR Doc. 2015–07958 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4184–40–P 

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 CHOLBAM 

(cholic acid), manufactured by 

Asklepion Pharmaceuticals, LLC, 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. 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), 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 

CHOLBAM (cholic acid), manufactured 

by Asklepion Pharmaceuticals, LLC, 

meets the criteria for a priority review 

voucher. CHOLBAM (cholic acid) is a 

bile acid indicated for the treatment of 

bile acid synthesis disorders due to 

single enzyme defects and as adjunctive 

treatment of peroxisomal disorders, 

including Zellweger spectrum disorders 

in patients who exhibit manifestations 

of liver disease or steatorrhea or 

complications from decreased fat 

soluble vitamin absorption. Bile acid 

synthesis disorders is a group of rare 

congenital disorders caused by the 

absence or malfunction of an enzyme 

involved in an important metabolic 

pathway, leading to a failure to produce 

normal bile acids. 

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/

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/

default.htm. 

For further information about 

CHOLBAM (cholic acid), go to the 

Drugs@FDA Web site at http://

www.accessdata.fda.gov/scripts/cder/

drugsatfda/index.cfm. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08016 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4164–01–P 

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 UNITUXIN 

(dinutuximab), manufactured by United 

Therapeutics Corporation, meets the 

criteria for a priority review voucher. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18629 

1Section 505–1 of the FD&C Act applies to 

applications for prescription drugs submitted under 

subsection 505(b) (i.e., new drug applications) or (j) 

(i.e., abbreviated new drug applications) of the 

FD&C Act (21 U.S.C. 355) and applications under 

section 351 of the Public Health Service Act (i.e., 

biologics license applications). 

2See http://www.fda.gov/RegulatoryInformation/

Legislation/FederalFoodDrugand

CosmeticActFDCAct/SignificantAmendmentsto

theFDCAct/FoodandDrugAdministration

AmendmentsActof2007/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Larry Bauer, Rare Diseases Program, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., 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), 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 

UNITUXIN (dinutuximab), 

manufactured by United Therapeutics 

Corporation, meets the criteria for a 

priority review voucher. UNITUXIN 

(dinutuximab) is indicated, in 

combination with granulocytemacrophage colony-stimulating factor 

(GM–CSF), interleukin-2 (IL–2), and 13- 

cis-retinoic acid (RA), for the treatment 

of pediatric patients with high-risk 

neuroblastoma who achieve at least a 

partial response to prior first-line 

multiagent, multimodality therapy. 

Neuroblastoma is the most common 

pediatric solid tumor occurring outside 

the brain, and it is the most common 

cancer in infants. 

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/

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. 

For further information about 

UNITUXIN (dinutuximab), go to the 

Drugs@FDA Web site at http://www.

accessdata.fda.gov/scripts/cder/

drugsatfda/index.cfm. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08014 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1747] 

Risk Evaluation and Mitigation 

Strategies: Modifications and 

Revisions; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Risk Evaluation and Mitigation 

Strategies: Modifications and 

Revisions.’’ This guidance provides 

information on how FDA will define 

and process submissions for 

modifications and revisions to risk 

evaluation and mitigation strategies 

(REMS), as well as information on what 

types of changes to approved REMS will 

be considered modifications of the 

REMS and what types of changes will be 

considered revisions of the REMS. 

There are different procedures for 

submission of REMS modifications and 

revisions to FDA as well as different 

timeframes for FDA review and action 

of such changes. In addition, this 

guidance provides information on how 

REMS modifications and revisions 

should be submitted to FDA and how 

FDA intends to review and act on these 

submissions. The definitions of REMS 

modifications and revisions apply to all 

types of REMS. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the guidance by June 8, 2015. Submit 

either electronic or written comments 

concerning the proposed collection of 

information by June 8, 2015. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave. Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave. Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kristen Everett, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 22, Rm. 6484, 

Silver Spring, MD 20993–0002, 301– 

796–0453; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave. Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Risk 

Evaluation and Mitigation Strategies: 

Modifications and Revisions.’’ This 

guidance provides information on what 

types of changes to approved REMS will 

be considered modifications and what 

types of changes will be considered 

revisions. See section 505–1(h) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355–1(h)). 

This guidance also provides information 

on how REMS modifications and 

revisions should be submitted to FDA 

and how FDA intends to review and act 

on these submissions. 

If FDA determines that a REMS is 

necessary to ensure that the benefits of 

a drug outweigh its risks, FDA is 

authorized to require a REMS for such 

drugs under section 505–1 of the FD&C 

Act,1 added by section 901 of the Food 

and Drug Administration Amendments 

Act of 2007 (Pub. L. 110–85).2 Section 

505–1(g) and (h) of the FD&C Act 

include provisions for the assessment 

and modification of an approved REMS. 

In 2009, FDA issued draft guidance on 

the format and content of REMS, REMS 

assessments, and proposed REMS 

modifications. In that guidance, based 

on the language of section 505–1(g) and 

(h) of the FD&C Act before the 

amendments made by the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

(FDASIA), FDA stated that any 

proposed modification to an approved 

REMS, including proposed changes to 

materials that are appended to the 

REMS document, must be submitted as 

a proposed REMS modification in the 

form of a prior approval supplement 

and must include a REMS assessment. 

The guidance stated that the proposed 

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