Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12495 

Abstract: The Rural Health Care 

Services Outreach (Outreach) Program is 

authorized by section 330A(e) of the 

Public Health Service (PHS) Act (42 

U.S.C. 254c(e)), as amended, to 

‘‘promote rural health care services 

outreach by expanding the delivery of 

health care services to include new and 

enhanced services in rural areas.’’ The 

goals for the Outreach Program are the 

following: (1) Expand the delivery of 

health care services to include new and 

enhanced services exclusively in rural 

communities; (2) deliver health care 

services through a strong consortium, in 

which every consortium member 

organization is actively involved and 

engaged in the planning and delivery of 

services; (3) utilize and/or adapt an 

evidence-based or promising practice 

model(s) in the delivery of health care 

services; and (4) improve population 

health and demonstrate health outcomes 

and sustainability. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were drafted to 

provide data to the program and to 

enable HRSA to provide aggregate 

program data required by Congress 

under the Government Performance and 

Results Act (GPRA) of 1993. These 

measures cover the principal topic areas 

of interest to the Federal Office of Rural 

Health Policy (FORHP), including: (a) 

Access to care; (b) population 

demographics; (c) staffing; (d) 

consortium/network; (e) sustainability; 

and (f) project specific domains. Several 

measures will be used for the Outreach 

Program. All measures will speak to 

FORHP’s progress toward meeting the 

goals. 

A 60-day Federal Register Notice was 

published in the Federal Register on 

December 22, 2014, (79 FR 76334). 

There were no comments. 

Likely Respondents: The respondents 

would be recipients of the Rural Health 

Care Services Outreach grant funding. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Rural Health Care Services Outreach Grant Program Measures ....... 50 1 50 3 150 

Total .............................................................................................. 50 1 50 3 150 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05414 Filed 3–6–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Date and Time: March 5, 2015, 10:00 

a.m. to 4:00 p.m. EDT. 

Place: Audio Conference Call and 

Adobe Connect Pro. 

The ACCV will meet on Thursday, 

March 5, 2015, from 10:00 a.m. to 4:00 

p.m. (EDT). The public can join the 

meeting by: 

1. (Audio Portion) Calling the 

conference Phone Number 877–917– 

4913 and providing the following 

information: 

Leader’s Name: Dr. A. Melissa 

Houston. 

Password: ACCV. 

2. (Visual Portion) Connecting to the 

ACCV Adobe Connect Pro Meeting 

using the following URL: https://

hrsa.connectsolutions.com/accv/ (copy 

and paste the link into your browser if 

it does not work directly, and enter as 

a guest). Participants should call and 

connect 15 minutes prior to the meeting 

in order for logistics to be set up. If you 

have never attended an Adobe Connect 

meeting, please test your connection 

using the following URL: https://

hrsa.connectsolutions.com/common/

help/en/support/meeting_test.htm and 

get a quick overview by following URL: 

http://www.adobe.com/go/connectpro_

overview. Call (301) 443–6634 or send 

an email to aherzog@hrsa.gov if you are 

having trouble connecting to the 

meeting site. 

Agenda: The agenda items for the 

March 2015 meeting will include, but 

are not limited to: updates from the 

Division of Injury Compensation 

Programs (DICP), Department of Justice 

(DOJ), National Vaccine Program Office 

(NVPO), Immunization Safety Office 

(Centers for Disease Control and 

Prevention), National Institute of 

Allergy and Infectious Diseases 

(National Institutes of Health) and 

Center for Biologics, Evaluation and 

Research (Food and Drug 

Administration). A draft agenda and 

additional meeting materials will be 

posted on the ACCV Web site (http://

www.hrsa.gov/vaccinecompensation/

accv.htm) prior to the meeting. Agenda 

items are subject to change as priorities 

dictate. 

Public Comment: Persons interested 

in providing an oral presentation should 

submit a written request, along with a 

copy of their presentation to: Annie 

Herzog, DICP, Healthcare Systems 

Bureau (HSB), Health Resources and 

Services Administration (HRSA), Room 

11C–26, 5600 Fishers Lane, Rockville, 

MD 20857 or email: aherzog@hrsa.gov. 

Requests should contain the name, 

address, telephone number, email 

address, and any business or 

professional affiliation of the person 

desiring to make an oral presentation. 

Groups having similar interests are 

requested to combine their comments 

and present them through a single 

representative. The allocation of time 

may be adjusted to accommodate the 

level of expressed interest. DICP will 

notify each presenter by email, mail, or 

telephone of their assigned presentation 

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12496 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

time. Persons who do not file an 

advance request for a presentation, but 

desire to make an oral statement, may 

announce it at the time of the public 

comment period. Public participation 

and ability to comment will be limited 

to space and time as it permits. 

The logistical challenges of 

scheduling this meeting delayed an 

earlier publication of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the ACCV should contact Annie Herzog, 

DICP, HSB, HRSA, Room 11C–26, 5600 

Fishers Lane, Rockville, Maryland 

20857, telephone (301) 443–6593, or 

email: aherzog@hrsa.gov. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05200 Filed 3–6–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 sections 

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 

Allergy and Infectious Diseases Special 

Emphasis Panel; ‘‘NIAID Resource-Related 

Research Projects (R24): Fecal Microbiome 

Transplant National Registry’’. 

Date: April 2, 2015. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3G61, 5601 Fishers Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: Travis J. Taylor, Ph.D., 

Scientific Review Program, DEA/NIAID/NIH/ 

DHHS, 5601 Fishers Lane, Rockville, MD 

20892, 240–669–5082, Travis.Taylor@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05309 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

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 meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Time-Sensitive 

Obesity Meeting. 

Date: March 26, 2015. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Michele L. Barnard, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 753, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, (301) 594–8898, 

barnardm@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK—Planning 

Grant in Chronic Kidney Disease (U34). 

Date: April 8, 2015. 

Time: 1:00 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Najma Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 749, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05308 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0390] 

Use of an Electronic Informed Consent 

in Clinical Investigations: Questions 

and Answers; Draft Guidance for 

Industry, Clinical Investigators, and 

Institutional Review Boards; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry, clinical 

investigators, and institutional review 

boards entitled ‘‘Use of Electronic 

Informed Consent in Clinical 

Investigations: Questions and Answers.’’ 

The guidance provides 

recommendations for clinical 

investigators, sponsors, and institutional 

review boards (IRBs) on the use of 

electronic media and processes to obtain 

informed consent for FDA-regulated 

clinical investigations of medical 

products, including human drug and 

biological products, medical devices, 

and combinations thereof. 

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 May 8, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft 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; or 

Office of Good Clinical Practice, Office 

of Special Medical Programs, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

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