69856 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.623] 

Announcement of the Award of a 

Single-Source Expansion Supplement 

Grant to National Safe Place in 

Louisville, KY 

AGENCY: Family and Youth Services 

Bureau (FYSB), ACYF, ACF, DHHS. 

ACTION: Notice of the award. 

SUMMARY: The Administration for 

Children and Families (ACF), 

Administration on Children, Youth and 

Families (ACYF), Family and Youth 

Services Bureau (FYSB), Division of 

Adolescent Development and Support 

(DADS) announces the award of a 

single-source expansion supplement 

grant of $610,000 to Safe Place in 

Louisville, KY, to support costs 

associated with the expansion of the 

scope of approved activities under their 

award for the Runaway and Homeless 

Youth Training and Technical 

Assistance Center (RHYTTAC). 

DATES: The award will support activities 

from August 1, 2014 through September 

29, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Holloway, Central Office 

Program Manager, Runaway and 

Homeless Youth Program, Division of 

Adolescent Development and Support, 

Family and Youth Services Bureau, 

1250 Maryland Avenue SW., Suite 800, 

Washington, DC 20024; Telephone: 

202–205–9560; Email: 

Christopher.Holloway@acf.hhs.gov 

SUPPLEMENTARY INFORMATION: The 

expansion supplement award will allow 

National Safe Place to: 

• Assist runaway and homeless youth 

(RHY) organizations with understanding 

and responding to the impact of toxic 

stress in the workplace through the 

creation of an annotated resource 

directory and distribution of other 

materials related to Toxic Stress 

Awareness and Response. 

• Provide training and technical 

assistance (T & TA) to RHY grantees on 

enhancing sustainability and for the 

development of an RHY Sustainability 

Toolkit containing an extensive 

compilation of generalized information 

for sustainability of RHY organizations. 

• Extend the Human Trafficking 

(HTR3) project to build upon and 

expand efforts in assisting programs 

with making the transition from 

understanding how to recognize and 

respect the victims of human trafficking 

to responding to the diverse needs of 

victims through the development of 

effective organizational practices and 

community collaborations. 

Using evidence-based practices 

derived from the best available research, 

professional expertise, and input from 

youth and families, the Runaway and 

Homeless Youth Training and Technical 

Assistance Center (RHYTTAC), operated 

by the National Safe Place, serves as the 

centralized national resource for FYSBfunded RHY grantees. Training and 

technical assistance services are 

directed to assisting RHY grantees in 

engaging in continuous quality 

improvement of their services and to 

assist them in building their 

organizational capacity to effectively 

serve RHY with a focus on helping the 

nation’s network of RHY service 

providers boost ‘‘protective factors’’ for 

their clients. 

Statutory Authority: Runaway and 

Homeless Youth Act, 42 U.S.C. 5701 through 

5752, amended by the Reconnecting 

Homeless Youth Act of 2008, Public Law 

110–378. 

Christopher Beach, 

Senior Grants Policy Specialist, Office of 

Administration, Division of Grants Policy. 

[FR Doc. 2014–27738 Filed 11–21–14; 8:45 am] 

BILLING CODE 4184–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0329] 

Fees for Human Drug Compounding 

Outsourcing Facilities Under the FD&C 

Act; 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 final guidance for 

industry entitled ‘‘Fees for Human Drug 

Compounding Outsourcing Facilities 

Under Sections 503B and 744K of the 

FD&C Act.’’ The guidance is intended 

for entities that compound human drugs 

and elect to register as outsourcing 

facilities under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as added 

by the Drug Quality and Security Act 

(DQSA). Entities that elect to register as 

outsourcing facilities must pay certain 

fees to be considered outsourcing 

facilities. This guidance describes the 

annual establishment fee, the 

reinspection fee, annual adjustments to 

fees required by law, how to submit 

payment, the effect of failure to pay fees, 

and how to qualify as a small business 

to obtain a reduction of the annual 

establishment fee. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

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. 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: 

Jonathan Gil, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Silver Spring, MD 20903, 301– 

796–7900. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Fees for Human Drug Compounding 

Outsourcing Facilities Under Sections 

503B and 744K of the FD&C Act.’’ On 

November 27, 2013, President Obama 

signed the DQSA (Pub. L. 113–54) into 

law. The DQSA added a new section 

503B to the FD&C Act (21 U.S.C. 353B) 

that created a category of entities called 

‘‘outsourcing facilities.’’ Section 

503B(d)(4) of the FD&C Act defines an 

outsourcing facility, in part, as a facility 

that complies with all of the 

requirements of section 503B, including 

registering with FDA as an outsourcing 

facility and paying associated fees. If the 

conditions outlined in section 503B(a) 

of the FD&C Act are satisfied, a drug 

compounded by or under the direct 

supervision of a licensed pharmacist in 

an outsourcing facility is exempt from 

certain sections of the FD&C Act, 

including section 502(f)(1) (21 U.S.C. 

352(f)(1)) (concerning the labeling of 

drugs with adequate directions for use) 

and section 505 (21 U.S.C. 355) 

(concerning the approval of human drug 

products under new drug applications 

(NDAs) or abbreviated new drug 

applications (ANDAs)). Drugs 

compounded in outsourcing facilities 

are not exempt from the requirements of 

section 501(a)(2)(B) of the FD&C Act (21 

U.S.C. 351(a)(2)(B)) (concerning current 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69857 

good manufacturing practice for drugs). 

This guidance describes in detail the fee 

types and amounts an entity must pay 

to satisfy the fee requirements of 

sections 503B and 744K of the FD&C 

Act to be deemed an outsourcing facility 

and maintain its status as an 

outsourcing facility, the adjustments to 

the fees required by law, how to qualify 

as a small business to obtain a reduction 

of the annual establishment fee, how 

and when to submit payment to FDA, 

the effect of failure to pay fees, and feerelated dispute resolution. 

On April 1, 2014 (79 FR 18297), FDA 

announced the availability of the draft 

version of this guidance. The public 

comment period closed on June 2, 2014. 

One comment was received from the 

public, and FDA carefully considered 

that comment as it finalized the 

guidance. Some of the issues raised 

relate to matters that FDA intends to 

address in other policy documents and 

were not directly pertinent to the topics 

addressed in this guidance. During 

finalization of the guidance, FDA made 

both clarifying changes and minor 

editorial changes to the guidance and 

accompanying form. For example, FDA 

clarified that it intends to issue an 

invoice for reinspection fees within 14 

calendar days of the close of the 

reinspection, and that the reinspection 

fee must be paid within 30 calendar 

days of the date of the invoice. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on fees associated with human 

drug compounding outsourcing 

facilities. 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. Comments 

Interested persons can 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 can 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. 

III. Paperwork Reduction Act of 1995 

This guidance contains collections of 

information that are subject to review by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520). The 

collections of information have been 

approved under OMB control number 

0910–0776. 

IV. Electronic Access 

Persons with access to the Internet 

can obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27692 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1428] 

Electronic Product Reporting for 

Human Drug Compounding 

Outsourcing Facilities; Draft Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a revised 

draft guidance entitled ‘‘Electronic 

Product Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ The 

revised draft guidance addresses 

provisions in the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) added 

by the Drug Quality and Security Act 

(DQSA) and updates reporting 

instructions for drug compounders that 

choose to register as outsourcing 

facilities. Such compounders must 

report information on the drugs they 

have compounded in Structured 

Product Labeling (SPL) format using 

FDA’s electronic submissions system. 

This revised draft guidance supersedes 

a draft guidance entitled ‘‘Interim 

Product Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ 

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 comments on this 

revised draft guidance, submit either 

electronic or written comments on the 

revised draft guidance by January 23, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the revised draft guidance by January 

23, 2015. 

ADDRESSES: Submit written requests for 

single copies of the revised draft 

guidance document 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. Send one self-addressed adhesive 

label to assist that office in processing 

your request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the revised draft guidance. 

Submit electronic comments on the 

revised 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: 

Lysette Deshields, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Electronic Product Reporting 

for Human Drug Compounding 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ In the Federal Register 

of December 4, 2013 (78 FR 72897), FDA 

issued a notice announcing the 

availability of an initial draft of this 

guidance entitled ‘‘Interim Product 

Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ That 

draft guidance addressed new 

provisions in the FD&C Act added by 

the DQSA and set forth an interim 

submission method for human drug 

compounders that choose to register as 

outsourcing facilities. 

The comment period on the initial 

draft guidance ended on February 3, 

2014. FDA received six comments on 

the draft. In response to received 

comments or on its own initiative, FDA 

made the following changes and 

updates in the revised draft guidance: 

(1) Modified the scope of the guidance 

to refer to product reports submitted in 

SPL format; (2) clarified the following 

elements required in a product report: 

‘‘Strength of the active ingredient per 

unit,’’ ‘‘package description,’’ and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES