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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18630 Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 

3See section 505–1(h)(2)(A)(ii) of the FD&C Act. 

4See section 505–1(h)(2)(A)(iv) of the FD&C Act. 

5See section 505–1(h)(2)(A)(iii) of the FD&C Act. 

modification(s) may not be 

implemented until approved by FDA. 

FDASIA amended the REMS 

modification provisions under section 

505–1(g) and (h) of the FD&C Act. 

Section 505–1(h), as amended by 

FDASIA, requires FDA to review and act 

on proposed ‘‘minor modifications,’’ as 

defined in guidance, within 60 days.3 It 

also requires FDA to establish, through 

guidance, that ‘‘certain modifications’’ 

can be implemented following 

notification to FDA.4 In addition, 

FDASIA requires FDA to review and act 

on REMS modifications due to approved 

safety label changes, or to a safety label 

change that FDA has directed the 

application holder to make pursuant to 

section 505(o)(4) of the FD&C Act 

within 60 days.5 Finally, FDASIA 

specifies that proposed REMS 

modifications no longer require 

submission of a REMS assessment; 

instead, proposed modifications must 

include an adequate rationale for the 

proposed changes. This guidance is 

issued pursuant to section 505– 

1(h)(2)(A)(ii), (h)(2)(A)(iii), and 

(h)(2)(A)(iv) of the FD&C Act. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance, except for the portion 

setting forth the submission procedures 

for REMS revisions, is being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). The 

Agency made this determination 

because, consistent with the 

requirements of FDASIA, FDA is issuing 

this guidance to establish a less 

burdensome policy and process for 

submitting certain changes to REMS that 

is consistent with public health. 

Although the guidance document is 

immediately in effect, except for the 

submission procedures for REMS 

revisions, it remains subject to comment 

in accordance with the Agency’s good 

guidance practices. Insofar as this 

guidance establishes the modifications 

to an approved REMS that may be 

implemented following notification to 

the Secretary under section 505– 

1(h)(2)(A)(iv)—here referred to as REMS 

revisions—it has binding effect, except 

for the portion of the guidance setting 

forth the submission procedure for 

REMS revisions, which will, when final, 

have binding effect. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The title, description, and 

respondent description of the 

information collection are given under 

this section with an estimate of the 

annual reporting burden. Included in 

the estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

We invite comments on these topics: 

(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 of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Guidance for Industry on Risk 

Evaluation and Mitigation Strategies: 

Modifications and Revisions 

Description: The guidance provides 

information on submitting to FDA 

modifications and revisions to approved 

REMS for approved new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), or biologics 

license applications (BLAs). 

REMS modifications are submitted to 

FDA as supplements to approved NDAs 

under 21 CFR 314.70 and for ANDAs 

under 21 CFR 314.97, and as 

supplements to approved BLAs under 

21 CFR 601.12. The burden hours for 

preparing and submitting supplements 

to NDAs and ANDAs is approved by 

OMB under control number 0910–0001, 

and for BLAs under control number 

0910–0338. 

Concerning REMS revisions, 

application holders should include the 

following information in each 

submission: (1) A full description of the 

changes to the REMS and/or appended 

materials, the date the changes will be 

implemented, and a REMS history that 

outlines all changes made to the REMS 

since its approval; (2) a clean Word 

version of the revised REMS and all 

appended REMS materials; (3) a 

redlined (tracked changes) Word version 

of the revised REMS and revised 

appended REMS materials that shows 

the changes from the previous versions; 

(4) an updated REMS supporting 

document, if needed; and (5) Form FDA 

356h indicating that the submission is a 

REMS revision. (Form FDA 356h is 

approved by OMB under control 

number 0910–0338.) Each REMS 

revision that is submitted to FDA 

should also be documented in the next 

annual report for the application under 

21 CFR 314.81(b)(2) (the burden hours 

for preparing and submitting annual 

reports for NDAs and ANDAs is 

approved by OMB under control 

number 0910–0001, and for BLAs under 

control number 0910–0338). All 

subsequent REMS submissions (i.e., 

proposed modifications or additional 

REMS revisions) should include 

previously implemented REMS 

revisions in the REMS document and 

appended materials, and should be 

noted in the REMS history. 

Currently, there are 117 application 

holders with approved REMS that 

include 152 drugs. Based on FDA’s 

current review of REMS submissions for 

approved NDAs, ANDAs, and BLAs, 

and anticipating an average of 1 REMS 

revision across the entire group of 

REMS, we estimate that annually a total 

of approximately 117 application 

holders (‘‘Number of Respondents’’ in 

table 1) will submit to FDA 

approximately 152 REMS revision 

submissions (‘‘Total Annual Responses’’ 

in table 1) as described in this document 

and in the guidance. We also estimate 

that it will take an application holder 

approximately 30 hours to prepare and 

submit to FDA each REMS revision 

(‘‘Average Burden per Response’’ in 

table 1). 

The total estimated reporting burden 

for the guidance is as follows: 

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Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18631 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance for industry on risk evaluation and mitigation 

strategies: modifications and revisions 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

REMS revisions ................................................................... 117 1 152 30 4,560 

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

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/default.htm, or 

http://www.regulations.gov. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08015 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Report of an 

Altered System of Records 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS or 

Department). 

ACTION: Notice of an Altered System of 

Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974 

(5 U.S.C. 552a), the Health Resources 

and Services Administration (HRSA) is 

publishing notice of a proposed 

alteration of the system of records 

entitled and numbered ‘‘Public Health 

and National Health Service Corps 

Scholarship Program (NHSC SP), 

National Health Service Corps Loan 

Repayment Program (NHSC LRP), 

Students to Service, (S2S), NHSC 

Student/Resident Experiences and 

Rotations in Community Health 

(SEARCH), NURSE Corps Loan 

Repayment Program (NURSE Corps 

LRP) formerly the Nursing Education 

Loan Repayment Program (NELRP), 

NURSE Corps Scholarship Program 

(NURSE Corps SP) formerly the Nursing 

Scholarship Program (NSP), Native 

Hawaiian Health Scholarship Program 

(NHHSP), and Faculty Loan Repayment 

Program (FLRP), Applicants and/or 

Participants Records System, HHS/

HRSA/BHW,’’ No. 09–15–0037. The 

proposed alterations affect the system 

name, system location, categories of 

records, purposes, routine uses, 

safeguards, records retention and 

disposal, system manager title and 

address, as well as minor editorial 

corrections and clarifications. 

DATES: HRSA filed an altered system 

report with the Chair of the House 

Committee on Government Reform and 

Oversight, the Chair of the Senate 

Committee on Homeland Security and 

Governmental Affairs, and the 

Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 

March 30, 2015. To ensure all parties 

have adequate time in which to 

comment, the altered system, including 

the routine uses, will become effective 

30 days from the publication of the 

notice or 40 days from the date it was 

submitted to OMB and Congress, 

whichever is later, unless HRSA 

receives comments that require 

alterations to this notice. 

ADDRESSES: Please address comments 

to: Associate Administrator, Bureau of 

Health Workforce (BHW), Health 

Resources and Services Administration 

(HRSA), 5600 Fishers Lane, Room 11W– 

37, Rockville, MD 20857, telephone 

(301) 594–4130, or FAX (301) 594–4076. 

Comments received will be available for 

inspection at this same address from 

9:00 a.m. to 3:00 p.m. (Eastern Standard 

Time Zone), Monday through Friday. 

FOR FURTHER INFORMATION CONTACT: 

BMISS System Manager, Bureau of 

Health Workforce, Health Resources and 

Services Administration (HRSA), 5600 

Fishers Lane, Room 11W–37, Rockville, 

MD 20857, Telephone: 301–443–1587. 

SUPPLEMENTARY INFORMATION: 

I. Explanation of Changes 

• The system of records notice name 

has been shortened to ‘‘HHS/HRSA/

BHW Scholarship and Loan Repayment 

Program Records.’’ 

• The Nursing Scholarship Program 

(NSP) has been renamed the NURSE 

Corps Scholarship Program (NURSE 

Corps SP), and the Nursing Education 

Loan Repayment Program (NELRP) has 

been renamed the NURSE Corps Loan 

Repayment Program (NURSE Corps 

LRP) and all associated records have 

been merged into a new central database 

system as noted below. 

• A new information system, BHW 

Management Information System 

Solution (BMISS), has replaced Bureau 

of Health Care Delivery and Assistance 

NET (BHCDANET), and serves as the 

central database for information 

concerning the, NHSC SP, NHSC LRP, 

S2S, NURSE Corps SP, NURSE Corps 

LRP, FLRP, and NHHSP. 

• The system location section has 

been updated to indicate that electronic 

records and electronic copies of paper 

records for applicants and participants 

under various programs are now stored 

in BMISS and to include locations of 

records not stored in BMISS (for 

example, Ambassador records are 

electronic but currently maintained in 

an online Web site directory while a 

BMISS database is being designed and 

built, at which point the records will be 

merged into BMISS). 

• The categories of records have been 

updated to include ‘‘information 

concerning educational loans.’’ 

• The purpose(s) section has been 

updated to consolidate certain 

descriptions (i.e., to combine the loan 

repayment and scholarship program 

monitoring activities previously 

described in purpose 4 with the other 

program selection and monitoring 

activities previously described in 

purpose 8), and to include intra-agency 

transfers of information previously 

described as routine uses by mistake 

(i.e., transfers to HHS’ debt and 

financial management systems). 

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