13382 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 

alternative regulatory approaches, we 

selected those approaches that would 

maximize net benefits. Based on the 

analysis that follows, the Department 

believes that these proposed priorities 

are consistent with the principles in 

Executive Order 13563. 

We also have determined that this 

regulatory action would not unduly 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

In accordance with both Executive 

Orders, the Department has assessed the 

potential costs and benefits, both 

quantitative and qualitative, of this 

regulatory action. The potential costs 

are those resulting from statutory 

requirements and those we have 

determined as necessary for 

administering the Department’s 

programs and activities. 

The benefits of the Disability and 

Rehabilitation Research Projects and 

Centers Program have been well 

established over the years. Projects 

similar to ones envisioned by the 

proposed priorities have been 

completed successfully, and the 

proposed priorities would generate new 

knowledge through research. The new 

DRRPs would generate, disseminate, 

and promote the use of new information 

that would improve outcomes for 

individuals with disabilities. 

Intergovernmental Review: This 

program is not subject to Executive 

Order 12372. 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF you must 

have Adobe Acrobat Reader, which is 

available free at the site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at: www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: March 3, 2015. 

Kathy Greenlee, 

Administrator. 

[FR Doc. 2015–05333 Filed 3–12–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in section 552b(c)(4) 

and 552b(c)(6), Title 5 U.S.C., as 

amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Wellstone Centers 

for Muscular Dystrophy. 

Date: April 27–28, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suite at the Chevy Chase 

Pavilion, Washington, DC 20115. 

Contact Person: Cathy J. Wedeen, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, NIH, 6100 Executive 

Boulevard, Room 5B01–G, Bethesda, MD 

20892–9304, (301) 435–6878, wedeenc@mail

.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: March 9, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05706 Filed 3–12–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0198] 

Current Good Manufacturing Practice 

Requirements for Combination 

Products; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period by 30 days to April 29, 

2015, for the notice entitled ‘‘Current 

Good Manufacturing Practice 

Requirements for Combination 

Products; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability,’’ that appeared in the 

Federal Register of January 27, 2015 (80 

FR 4280). In that document, FDA 

announced the availability of a draft 

guidance for industry and FDA staff and 

requested comments. The Agency is 

taking this action in response to a 

request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance. Submit 

either electronic or written comments 

by April 29, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Current Good 

Manufacturing Practice Requirements 

for Combination Products’’ to the Office 

of Combination Products, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5129, 

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 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13383 

MD 20993–0002, 301–796–8930, email: 

John.Weiner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 27, 

2015 (80 FR 4280), FDA published a 

notice with a 60-day comment period to 

request comments on the draft guidance 

for industry and FDA staff entitled 

‘‘Current Good Manufacturing Practice 

Requirements for Combination 

Products.’’ 

The Agency received a request for a 

30-day extension of the comment period 

for the draft guidance. The request 

conveyed concern that the current 60- 

day comment period does not allow 

sufficient time to respond. FDA has 

considered the request and is extending 

the comment period for the draft 

guidance for 30 days, until April 29, 

2015. The Agency believes that a 30-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying further 

FDA action on this guidance document. 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Regulatory

Information/Guidances/ucm126198.htm 

or http://www.regulations.gov. 

Dated: March 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05674 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Advisory Committee for Women’s 

Services (ACWS); Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given of a meeting of 

the Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Advisory Committee for Women’s 

Services (ACWS) on April 15, 2015. 

The meeting will include discussions 

on lesbian, bisexual and transgender 

issues; high-risk/high-need girls and 

young women; supporting women in coed settings—core competencies, 

practices and strategies; SAMHSA’s 

Pregnant and Post-Partum Women Grant 

Program; and a conversation with the 

SAMHSA Administrator. 

The meeting is open to the public and 

will be held at SAMHSA, 1 Choke 

Cherry Road, Rockville, MD 20850, in 

the Rock Creek Conference Room. 

Attendance by the public will be limited 

to space available. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. Written 

submissions should be forwarded to the 

contact person (below) on or before 

April 7, 2015. Oral presentations from 

the public will be scheduled at the 

conclusion of the meeting. Individuals 

interested in making oral presentations 

are encouraged to notify the contact 

person on or before April 7, 2015. Five 

minutes will be allotted for each 

presentation. 

The meeting may be accesed via 

telephone. To attend on site, obtain the 

call-in number and access code, submit 

written or brief oral comments, or 

request special accommodations for 

persons with disabilities, please register 

on-line at: http://nac.samhsa.gov/

Registration/meetingsRegistration.aspx, 

or communicate with SAMHSA’s 

Designated Federal Officer, Ms. Nadine 

Benton (see contact information below). 

Substantive meeting information and 

a roster of Committee members may be 

obtained either by accessing the 

SAMHSA Committees’ Web site at: 

http://www.samhsa.gov/about-us/ 

advisory-councils/advisory-committeewomen%E2%80%99s-services-awcs, or 

by contacting Ms. Benton. 

Committee Name: Substance Abuse 

and Mental Health Services 

Administration Advisory Committee for 

Women’s Services (ACWS). 

Date/Time/Type: Wednesday, April 

15, 2015, from 9:00 a.m. to 5:15 p.m. 

EDT: Open. 

Place: SAMHSA, 1 Choke Cherry 

Road, Rock Creek Conference Room, 

Rockville, Maryland 20850. 

Contact: Nadine Benton, Designated 

Federal Official, SAMHSA’s Advisory 

Committee for Women’s Services, 1 

Choke Cherry Road, Rockville, 

Maryland 20857 (mail), Telephone: 

(240) 276–0127, Fax: (240) 276–2252, 

Email: nadine.benton@samhsa.hhs.gov. 

Summer King, 

Statistician, SAMHSA. 

[FR Doc. 2015–05816 Filed 3–12–15; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Prevention; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Prevention 

(CSAP) Drug Testing Advisory Board 

(DTAB) will meet via web conference on 

April 9, 2015, from 10:00 a.m. to 3:30 

p.m. E.D.T. 

The Board will meet in closed session 

to discuss confidential research data, as 

well as proposed revisions to the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs. 

Therefore, this meeting is closed to the 

public as determined by the 

Administrator, SAMHSA, in accordance 

with 5 U.S.C. 552b(c)(4), 5 U.S.C. 

552b(c)(9)(B), and 5 U.S.C. App. 2, 

Section 10(d). 

Meeting information and a roster of 

DTAB members may be obtained by 

accessing the SAMHSA Advisory 

Committees Web site, http://www.

samhsa.gov/about-us/advisory-councils/

drug-testing-advisory-board-dtab, or by 

contacting Dr. Cook. 

Committee Name: Substance Abuse and 

Mental Health Services Administration’s 

Center for Substance Abuse Prevention Drug 

Testing Advisory Board. 

Dates/Time/Type: April 9, 2015, from 

10:00 a.m. to 3:30 p.m. E.D.T.: CLOSED. 

Place: SAMHSA Building, 1 Choke Cherry 

Road, Rockville, Maryland 20850. 

Contact: Janine Denis Cook, Ph.D., 

Designated Federal Official, CSAP Drug 

Testing Advisory Board, 1 Choke Cherry 

Road, Room 7–1043, Rockville, Maryland 

20857, Telephone: 240–276–2600, Fax: 240– 

276–2610, Email: janine.cook@

samhsa.hhs.gov. 

Janine Denis Cook, 

Designated Federal Official, DTAB, Division 

of Workplace Programs, Center for Substance 

Abuse Prevention, Substance Abuse and 

Mental Health Services Administration. 

[FR Doc. 2015–05749 Filed 3–12–15; 8:45 am] 

BILLING CODE 4162–20–P 

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