Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 68451 

contact Linda Tavener at 410–786– 

3838). 

Dated: November 12, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–27135 Filed 11–14–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Announcing the Award of a SingleSource Program Expansion 

Supplement Grant to the Futures 

Without Violence in San Francisco, CA 

AGENCY: Family and Youth Services 

Bureau, ACYF, ACF, HHS. 

ACTION: Notice of the award of a singlesource program expansion supplement 

grant under the Family Violence 

Prevention and Services Act (FVPSA) 

Technical Assistance (TA) Project to the 

Futures Without Violence to support 

training and technical assistance 

activities. 

CFDA Number: 93.592. 

SUMMARY: The Administration for 

Children and Families (ACF), 

Administration on Children, Youth and 

Families (ACYF), Family and Youth 

Services Bureau (FYSB), Division of 

Family Violence Prevention and 

Services (DFVPS) announces the award 

of $270,000 as a single-source program 

expansion supplement to Futures 

Without Violence in San Francisco, CA. 

The grantee, funded under the Family 

Violence Protection and Services Act 

(FVPSA) program, is a technical 

assistance (TA) provider that serves as 

the FVPSA-funded National Health 

Resource Center on Domestic Violence. 

DATES: The period of support is 

September 30, 2014 through September 

29, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Shawndell Dawson, Senior Program 

Specialist, Family Violence Prevention 

and Services Program, 1250 Maryland 

Avenue SW., Suite 8219, Washington, 

DC 20024. Telephone: 202–205–1476; 

Email: Shawndell.Dawson@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Supplemental award funds will support 

the grantee in providing training and 

technical assistance to domestic 

violence service and health care 

providers. A portion of the 

supplemental award is contributed by 

the Health Resources and Services 

Administration (HRSA) and the Office 

on Women’s Health (OWH) at the 

Department of Health and Human 

Services (HHS). 

This award will expand the scope of 

Futures Without Violence’s technical 

assistance activities to include 

additional activities on the following 

issues: Assessing and responding to 

domestic violence in health clinics; 

addressing dating violence and sexual 

assault on college campuses; and 

supporting children/youth experiencing 

domestic violence. This additional 

technical assistance and training may 

involve such activities as: 

• Planning, coordinating, and 

evaluating a pre-conference institute on 

Sexual Assault and Dating Violence on 

College Campuses, as part of the 2015 

National Conference on Health and 

Domestic Violence; 

• providing technical assistance for 

three health centers to create health 

system changes that support providers 

and create sustainable responses to 

victims of intimate partner violence; 

• providing training on 

comprehensive, culturally competent 

responses to domestic violence within a 

Patient Centered Medical Home model. 

• creating new technical assistance 

resources that promote protective 

factors and resilience when working 

with children, youth, and teens 

impacted by domestic violence which 

includes fostering stronger relationships 

with their non-abusive parents or 

caregivers; 

• providing training to domestic 

violence programs that improves 

consistent implementation of evidenceinformed, trauma-informed, and 

culturally relevant programming for 

children, youth, and abused parents; 

and, 

• developing new resources for the 

Web site, www.PromisingFutures

WithoutViolence.org. 

Statutory Authority: The statutory 

authority for the FVSPA Program is under 

section 310 of the FVPSA, as amended by 

Section 201 of the CAPTA Reauthorization 

Act of 2010, Pub. L. 111–320. The Office on 

Women’s Health authority for its additional 

funds is through Sections 1701(a)(3)(A), 

1701(a)(5), and 1701(a)(8) of the Public 

Health Service Act; and the Economy Act (31 

U.S.C. 1535/FAR 17.5). HRSA’s authority for 

its funds is through Section 330 of the Public 

Health Service Act (42 U.S.C. § 254b). 

Christopher Beach, 

Senior Grants Policy Specialist, Office of 

Administration, Office of Financial Services, 

Division of Grants Policy. 

[FR Doc. 2014–27131 Filed 11–14–14; 8:45 am] 

BILLING CODE 4184–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1461] 

Rare Pediatric Disease Priority Review 

Vouchers, Draft 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 draft guidance for 

industry entitled ‘‘Rare Pediatric 

Disease Priority Review Vouchers.’’ 

Under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), FDA will 

award priority review vouchers to 

sponsors of certain rare pediatric 

disease product applications that meet 

the criteria specified in that section. 

These vouchers can be used when 

submitting future human drug 

marketing applications that would not 

otherwise qualify for priority review. 

These vouchers can be sold or 

transferred for use to another sponsor 

any number of times before the voucher 

is used, as long as the sponsor making 

the transfer has not yet submitted the 

application. Because there exists a need 

for products for rare pediatric diseases, 

this program is intended to encourage 

development of new drug and biological 

products for prevention and treatment 

of certain rare pediatric diseases. 

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 draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by January 16, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the draft guidance by January 16, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communications, Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002, or Office 

of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, Bldg. 71, Rm. 

3128, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002; or Office 

of Orphan Products Development, 

Office of Special Medical Programs, 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
68452 Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993. Send one self-addressed 

adhesive label to assist the office that 

will be processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft 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: 

Henry Startzman, Food and Drug 

Administration, Office of Orphan 

Products Development, Bldg. 32, Rm. 

5295, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–8660. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Rare Pediatric Disease Priority Review 

Voucher.’’ 

This draft guidance clarifies FDA’s 

plans to implement section 908 of the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), which 

added section 529 to the Federal Food 

Drug and Cosmetic Act (21 U.S.C. 360ff) 

(the FD&C Act). Under this statutory 

section, a sponsor who receives an 

approval for a drug or biological product 

to treat or prevent a rare pediatric 

disease (as defined by statute) may, if 

the statute’s criteria are met, qualify for 

a voucher which can be used to receive 

a priority review for a subsequent 

marketing application for a different 

product. The draft guidance is intended 

to assist developers of rare pediatric 

disease products in assessing whether 

their product may be eligible for rare 

pediatric disease designation and a rare 

pediatric disease priority review 

voucher. It also clarifies the process for 

requesting such designations and 

vouchers, sponsor responsibilities upon 

approval of a rare pediatric disease 

product application, and the parameters 

for using and transferring a rare 

pediatric disease priority review 

voucher. 

The draft guidance provides FDA’s 

interpretation of a variety of terms in the 

statute. It defines ‘‘rare pediatric 

disease’’ as a disease or condition with 

an entire prevalence of less than 

200,000 in the United States and with 

more than 50 percent of patients living 

with the disease aged 0 through 18 

years. It provides sponsors information 

on how to calculate and document 

prevalence in their requests for 

designation. It explains that, in order for 

an application to qualify for a rare 

pediatric disease priority review 

voucher, it must meet several statutory 

requirements, including being for a 

human drug that contains no active 

ingredient (including any ester or salt of 

the active ingredient) that has been 

previously approved in any other 

application under section 505(b)(1), 

505(b)(2), or 505(j) of the FD&C Act (21 

U.S.C. 355(b)(1), 355(b)(2), or 355(j)) or 

section 351(a) or 351(k) of the Public 

Health Service Act (42 U.S.C. 262(a) or 

42 U.S.C. 262(k). 

The draft guidance also outlines for 

sponsors the procedures for requesting 

rare pediatric disease designation and 

rare pediatric disease priority review 

vouchers and describes the information 

to include in the designation request 

and the voucher request. Additionally, 

it describes how FDA will respond to 

requests for rare pediatric disease 

designation and vouchers. 

Finally, the draft guidance describes 

the processes by which a rare pediatric 

disease priority review voucher is to be 

awarded, used, and transferred to 

another sponsor. This draft guidance is 

being issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on Rare Pediatric 

Disease Priority Review Vouchers. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comment on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection on respondents, 

including through the use of automated 

collection techniques and other forms of 

information technology, when 

appropriate. 

Title: Rare Pediatric Disease Priority 

Review Vouchers, Draft Guidance for 

Industry. 

Description of Respondents: 

Respondents to this collection of 

information are sponsors that develop 

drugs and biological products. 

Burden Estimate: This draft guidance 

on Rare Pediatric Disease Priority 

Review Vouchers is intended to assist 

developers of rare pediatric disease 

products in assessing whether their 

product may be eligible for rare 

pediatric disease designation and a rare 

pediatric disease priority review 

voucher. 

The draft guidance clarifies the 

process for requesting such designations 

and vouchers, sponsor responsibilities 

upon approval of a rare pediatric 

disease product application, and the 

parameters for using and transferring a 

rare pediatric disease priority review 

voucher. 

FDA has OMB approval under the 

PRA for the submission of new drug 

applications (NDAs) and related 

submissions under 21 CFR part 314 

(OMB control number 0910–0001), 

biologics license applications (BLAs) 

and related submissions under 21 CFR 

part 601 (OMB control number 0910– 

0338), and orphan-drug designation 

requests and related submissions under 

21 CFR part 316 (OMB control number 

0910–0167). The draft guidance 

describes five collections of information 

that are not currently approved by OMB 

under the PRA: (1) The request for a rare 

pediatric disease designation, (2) the 

request for a rare pediatric disease 

priority review voucher, (3) the 

notification of intent to use a voucher, 

(4) the notification to transfer a voucher, 

and (5) the post-approval report. 

These collections of information will 

be used by the Agency to issue rare 

pediatric disease designations and 

vouchers, prepare for an incoming 

priority review, and maintain awareness 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 68453 

about which sponsors currently hold 

vouchers. 

A. Request for Rare Pediatric Disease 

Designation 

Under the draft guidance, a 

stakeholder interested in obtaining a 

rare pediatric disease designation 

should include information about the 

drug product and its proposed 

mechanism of action, a description of 

the rare pediatric disease for which the 

drug is being or will be investigated, 

and documentation that the disease or 

condition for which the drug is 

proposed is a ‘‘rare pediatric disease’’ as 

defined in section 529(a)(3) of the FD&C 

Act. 

FDA estimates that annually a total of 

approximately 30 respondents will 

complete one rare pediatric disease 

designation request as described in 

question 8 of the draft guidance. FDA 

estimates that preparing these 

designation requests will take 

approximately 75 hours for each 

designation request. This includes the 

time that may be needed to respond to 

FDA actions and requests. 

B. Request for Rare Pediatric Disease 

Priority Review Voucher 

As described more fully in the draft 

guidance, the information to be 

provided in a request for a priority 

review voucher will depend on whether 

the sponsor has previously received rare 

pediatric disease designation. Sponsors 

who have received rare pediatric disease 

designation will include the designation 

letter with the voucher request 

explaining how the application meets 

all of the remaining eligibility criteria. 

Sponsors who have not requested rare 

pediatric disease designation should 

include in a voucher request prevalence 

estimates as of the time of NDA/BLA 

submission, with supporting 

documentation, and explain how the 

application meets all of the remaining 

eligibility criteria. 

We estimate that annually a total of 

approximately 20 respondents will 

complete one rare pediatric disease 

priority review voucher request as 

described in response to question 14 of 

the draft guidance. We estimate that 

preparing these designation requests 

will take approximately 40 hours for 

each rare pediatric disease priority 

review voucher request. This includes 

the time that may be needed to respond 

to FDA actions and requests. 

C. Notification of Intent To Use Voucher 

The sponsor redeeming a rare 

pediatric disease voucher must notify 

FDA of its intent to submit an 

application with a priority review 

voucher at least 90 days before 

submission of the application, and must 

include the date the sponsor intends to 

submit the application. 

FDA estimates that annually a total of 

approximately 3 respondents will 

complete one Notification of Intent to 

Use a Voucher as described in response 

to question 18 of the draft guidance. We 

estimate that preparing each of these 

Notifications of Intent to Use a Voucher 

will take approximately 8 hours. 

D. Transfer Notification 

Each person to whom a voucher is 

transferred must notify FDA of the 

change of voucher ownership within 30 

days after the transfer. This notification 

should include a letter from the 

previous owner to the current owner 

and a letter from the current owner to 

the previous owner, each 

acknowledging the transfer. Any 

sponsor redeeming a voucher should 

include these transfer letters in the 

application submitted to FDA. A 

complete record of transfer must be 

made available to FDA to redeem a 

transferred voucher. 

FDA estimates that annually a total of 

approximately 2 respondents will 

complete Transfer Notifications as 

described in response to question 20 of 

the draft guidance. We estimate that 

preparing each of these Transfer 

Notifications will take approximately 8 

hours. 

E. Post-Approval Report 

The sponsor of an approved rare 

pediatric disease product application 

must submit a report to FDA no later 

than 5 years after approval that 

addresses the following, for each of the 

first four post-approval years: (1) The 

estimated population in the United 

States with the rare pediatric disease for 

which the product was approved (both 

the entire population and the 

population aged 0 through 18 years); (2) 

The estimated demand in the United 

States for the product; and (3) the actual 

amount of product distributed in the 

United States. 

FDA estimates that annually a total of 

approximately 2 respondents will 

complete post-approval reports, as 

described in response to question 6 of 

the draft guidance. We estimate that 

each of these post-approval reports will 

take about 20 hours to complete. 

The total estimated annual reporting 

burdens for the draft guidance are as 

follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Description of burden Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Rare pediatric disease designation request ........................ 30 1 30 75 2,250 

Rare pediatric disease priority review voucher request ...... 20 1 20 40 800 

Notification of intent to use a voucher ................................. 3 1 3 8 24 

Transfer notification ............................................................. 2 1 2 8 16 

Post-approval report ............................................................ 2 1 2 20 40 

Total burden hours ....................................................... ........................ ........................ ........................ ........................ 3,130 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Send comments regarding this burden 

estimate or suggestions for reducing this 

burden to: Office of Orphan Products 

Development, Food and Drug 

Administration, Bldg. 32, Rm. 5295, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
68454 Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at: http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/default.htm, or http:// 

www.regulations.gov. 

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27022 Filed 11–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1285] 

Smith Miller and Patch, Inc. et al.; 

Withdrawal of Approval of 14 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 14 new drug applications 

(NDAs) from multiple holders of these 

applications. The basis for the 

withdrawals is that the holders of the 

applications have repeatedly failed to 

file required annual reports for the 

applications. 

DATES: November 17, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new drugs for human use are 

required to submit annual reports to 

FDA concerning each of their approved 

applications in accordance with 

§ 314.81 (21 CFR 314.81). 

In the Federal Register of November 

6, 2013 (78 FR 66748), FDA published 

a notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of 14 NDAs because 

the firms had failed to submit the 

required annual reports for these 

applications. The holders of these 

applications did not respond to the 

NOOH. Failure to file a written notice 

of participation and request for hearing 

as required by § 314.200 (21 CFR 

314.200) constitutes an election by the 

applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, the 

Director, Center for Drug Evaluation and 

Research, is withdrawing approval of 

the 14 applications listed in table 1 of 

this document. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug Applicant 

NDA 004979 .............. Multi-Vitamin Tablets ............................................................ Smith Miller and Patch Inc., P.O. Box 367, San German, 

PR 00753. 

NDA 008176 .............. Methostan (methandriol) Tablets ......................................... Do. 

NDA 008326 .............. Methischol (inositol/vitamin B12/racemethionine/choline 

chloride) Injection.

USV Pharmaceutical Corp., 500 Virginia Dr., Fort Washington, PA 19034–2779. 

NDA 008362 .............. Corticotropin Injection .......................................................... Vitarine Pharmaceuticals Inc., 227–15 North Conduit Ave., 

Springfield Gardens, NY 11413. 

NDA 009346 .............. ACTH (corticotropin) Injection .............................................. Parke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950. 

NDA 009515 .............. Hyrye (riboflavin 5′-phosphate sodium) Injection ................. S.F. Durst and Co., Inc., 5317–21 North Third St., Philadelphia, PA 19120. 

NDA 010415 .............. Flamotide (riboflavin 5′-phosphate sodium) Injection .......... Philadelphia Ampoule Laboratories, 400 Green St., Philadelphia, PA 19123. 

NDA 010565 .............. Duracton (corticotropin) Injection ......................................... Nordic Biochemicals Inc., 45 Bay State Rd., Boston, MA 

02215. 

NDA 010791 .............. Rubivite (cyanocobalamin) Injection .................................... Bel Mar Laboratories, Inc., 6–10 Nassau Ave., Inwood, NY 

11696. 

NDA 010831 .............. Corticotropin Injection .......................................................... Organics/LaGrange, Inc., 1935 Techny Rd., suite 14, 

Northbrook, IL 60062. 

NDA 011015 .............. RU–B–12–1000 (cyanocobalamin) Injection ........................ Dow Pharmaceutical Corp., 9550 North Zionsville Rd., Indianapolis, IN 46268. 

NDA 011578 .............. Efacin (niacin) Tablet ........................................................... Person and Covey, Inc., 616 Allen Ave., Glendale, CA 

91201. 

NDA 017861 .............. Acthar Gel Synthetic (seractide acetate) Injection .............. Armour Pharmaceutical Co., P.O. Box 511, Kankakee, IL 

60901. 

NDA 018087 .............. Thyrel TRH (protirelin) Injection ........................................... Ferring Pharmaceuticals, Inc., 400 Rella Blvd., suite 300, 

Suffern, NY 10901. 

The Director, Center for Drug 

Evaluation and Research, under section 

505(e) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(e)), and 

under authority delegated by the 

Commissioner, finds that the holders of 

the applications listed in this document 

have repeatedly failed to submit reports 

required by § 314.81. In addition, under 

§ 314.200, we find that the holders of 

the applications have waived any 

contentions concerning the legal status 

of the drug products. Therefore, under 

these findings, approval of the 

applications listed in this document, 

and all amendments and supplements 

thereto, is hereby withdrawn, effective 

November 17, 2014. 


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