22206 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 

marketing decision. These challenges 

may include differences between the 

OUS and U.S. clinical conditions, 

regulatory requirements (including 

human subject protections), and/or 

study populations that may be sufficient 

to affect the adequacy of the data for use 

in establishing the safety and/or 

effectiveness of the studied device. This 

guidance focuses on considerations 

sponsors of device submissions should 

take into account when initiating, or 

relying on previously collected data 

from, an OUS clinical study to support 

an Investigational Device Exemption, 

Premarket Notification (510(k)), De 

Novo Petition, Humanitarian Device 

Exemption, or Premarket Approval 

Application. This guidance also notes 

other important considerations to take 

into account when initiating or relying 

on OUS data. FDA believes that 

promoting greater clarity concerning 

FDA’s use of foreign study data will 

minimize the possibility for additional 

or duplicative U.S. studies, further 

efforts to harmonize global clinical trial 

standards, and promote public health 

and innovation. 

II. Significance of Guidance 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 acceptance of clinical data from 

foreign studies conducted OUS. 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Centers for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Acceptance of Medical Device 

Clinical Data from Studies Conducted 

Outside the United States; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1741 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to currently 

approved collections of information 

found in FDA regulations. These 

collections of information 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 collections of information in 

21 CFR parts 50 and 56 have been 

approved under OMB control number 

0910–0755; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR parts 801 and 

809 have been approved under OMB 

control number 0910–0485; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 812 has been approved under OMB 

control number 0910–0078; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; the 

collections of information in 21 CFR 

part 814, subpart H have been approved 

under OMB control number 0910–0332; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

V. 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. 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09176 Filed 4–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), announcement is 

made of the following National 

Advisory body scheduled to meet 

during the month of May 2015. 

The National Advisory Committee on 

Rural Health and Human Services will 

convene its seventy seventh meeting in 

the time and place specified below: 

Name: National Advisory Committee 

on Rural Health and Human Services. 

Dates and Time: May 27, 2015, 8:45 

a.m.—5:00 p.m.; May 28, 2015, 8:30 

a.m.—5:15 p.m.; May 29, 2015, 8:30 

a.m.—11:00 a.m. 

Place: Natural Bridge State Park, 2135 

Natural Bridge Rd, Slade, KY 40376, 

(606) 663–2214. 

Status: The meeting will be open to 

the public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides counsel and 

recommendations to the Secretary with 

respect to the delivery, research, 

development, and administration of 

health and human services in rural 

areas. 

Agenda: Wednesday morning, at 8:45 

a.m., the meeting will be called to order 

by the Chairperson of the Committee: 

The Honorable Ronnie Musgrove. The 

Committee will examine the issue of an 

increasing difference between life 

expectancy among the urban and rural 

populations of the United States. The 

day will conclude with a period of 

public comment at approximately 4:45 

p.m. 

Thursday morning at approximately 

8:30 a.m., the Committee will break into 

Subcommittees and depart for site 

visits. Subcommittees will visit the 

Center of Excellence in Rural Health in 

Hazard, Kentucky, and the Marcum & 

Wallace Memorial Hospital in Irvine, 

Kentucky. The day will conclude at the 

Natural Bridge State Park with a period 

of public comment at approximately 

5:00 p.m. 

Friday morning at 8:30 a.m., the 

Committee will meet to summarize key 

findings and develop a work plan for 

the next quarter and the following 

meeting. 

FOR FURTHER INFORMATION CONTACT: 

Steve Hirsch, MSLS, Executive 

Secretary, National Advisory Committee 

on Rural Health and Human Services, 

Health Resources and Services 

Administration, Parklawn Building, 

17W29–C, 5600 Fishers Lane, Rockville, 

MD 20857, Telephone (301) 443–0835, 

Fax (301) 443–2803. 

Persons interested in attending any 

portion of the meeting should contact 

Catherine Fontenot at the Federal Office 

of Rural Health Policy (FORHP) via 

telephone at (301) 945–0897 or by email 

at cfontenot@hrsa.gov. The Committee 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22207 

meeting agenda will be posted on the 

Committee’s Web site at http://

www.hrsa.gov/advisorycommittees/

rural/. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–09080 Filed 4–20–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on the 

National Health Service Corps; 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: National Advisory Council on 

the National Health Service Corps 

(NAC). 

Date and Time: May 6, 2015 from 2:00 

p.m.–3:30 p.m. (EST). 

Place: Conference Call Format. 

Status: The meeting will be open to 

the public. 

Purpose: The NAC provides advice to 

the Secretary of the Department of 

Health and Human Services and the 

Administrator of the Health Resources 

and Services Administration (HRSA), 

with respect to their responsibilities for 

designating areas of the United States 

with critical health professional 

shortages (i.e., Health Professional 

Shortage Area) and assigning health care 

personnel to improve the delivery of 

health services in these areas. 

Agenda: The members of the NAC 

will discuss: (a) The activities and goals 

for fiscal year 2016 for the National 

Health Service Corps; (b) their vision 

and approaches for future NAC 

meetings; and (c) planning for an inperson meeting. The official agenda will 

be available 2 days prior to the meeting 

on the HRSA Web site at: http://

nhsc.hrsa.gov/corpsexperience/aboutus/

nationaladvisorycouncil/. Agenda items 

are subject to change as priorities 

dictate. 

Public Comment: Requests to make 

oral comments or provide written 

comments to the NAC should be sent to 

CAPT Shari Campbell, Designated 

Federal Official, using the address and 

phone number below. Individuals who 

plan to participate on the conference 

call should notify CAPT Campbell at 

least 3 days prior to the meeting, using 

the address and phone number below. 

Members of the public will have the 

opportunity to provide comments. 

Interested parties should refer to the 

meeting, in the subject line, as the 

HRSA National Advisory Council on the 

National Health Service Corps. The 

conference call-in number is: 888–566– 

5974. The passcode is: 4439136. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requesting information 

regarding the NAC should contact CAPT 

Shari Campbell, Designated Federal 

Official, Bureau of Health Workforce, 

HRSA, in one of three ways: (1) Send a 

request to the following address: CAPT 

Shari Campbell, Designated Federal 

Official, Bureau of Health Workforce, 

HRSA, Parklawn Building, Room 8C–26, 

5600 Fishers Lane, Rockville, Maryland 

20857; (2) call (301) 594–4251; or (3) 

send an email to scampbell@hrsa.gov. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–09078 Filed 4–20–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than May 21, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Enrollment and Re-Certification of 

Entities in the 340B Drug Pricing 

Program and Collection of Manufacturer 

Data to Verify 340B Drug Pricing 

Program Ceiling Price Calculations. 

OMB No. 0915–0327—Revision 

Abstract: Section 602 of Public Law 

102–585, the Veterans Health Care Act 

of 1992, enacted as Section 340B of the 

Public Health Service Act (PHS Act; 

‘‘Limitation on Prices of Drugs 

Purchased by Covered Entities’’), 

provides that a manufacturer who sells 

covered outpatient drugs to eligible 

entities must sign a Pharmaceutical 

Pricing Agreement (PPA) with the 

Secretary of Health and Human Services 

in which the manufacturer agrees to 

charge a price for covered outpatient 

drugs that will not exceed an amount 

determined under a statutory formula 

(‘‘ceiling price’’). 

A manufacturer subject to a PPA must 

offer all covered outpatient drugs at no 

more than the ceiling price to a covered 

entity listed in the 340B Program 

database. Manufacturers rely on the 

information in the 340B database to 

determine if a covered entity is 

participating in the 340B Program or for 

any notifications of changes to 

eligibility that may occur within a 

quarter. By signing the PPA, the 

manufacturer agrees to comply with all 

applicable statutory and regulatory 

requirements, including any changes 

that occur after execution of the PPA. 

Covered entities which choose to 

participate in the 340B Program must 

comply with the requirements of 

Section 340B(a)(5) of the PHS Act. 

Section 340B(a)(5)(A) prohibits a 

covered entity from accepting a 

discount for a drug that would also 

generate a Medicaid rebate. Further, 

Section 340B(a)(5)(B) prohibits a 

covered entity from reselling or 

otherwise transferring a discounted drug 

to a person who is not a patient of the 

entity. 

Need and Proposed Use of the 

Information: Section 340B(d)(1)(B)(i) of 

the PHS Act requires the development 

of a system to enable the Secretary to 

verify the accuracy of ceiling prices 

calculated by manufacturers under 

subsection (a)(1) and charged to covered 

entities, which shall include the 

following: 

(I) Developing and publishing through 

an appropriate policy or regulatory 

issuance, precisely defined standards 

and methodology for the calculation of 

ceiling prices under such subsection. 

(II) Comparing regularly the ceiling 

prices calculated by the Secretary with 


tkelley on DSK3SPTVN1PROD with NOTICES