Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78449 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

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draft guidance to http://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: 

Jennifer Dickey, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5262, Silver Spring, 

MD 20993–0002, 301–796–5028. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides 

recommendations to assist industry in 

designing studies to establish the 

analytical and clinical performance 

characteristics of radiation biodosimetry 

medical countermeasure devices. 

Radiation biodosimetry 

countermeasure devices are devices 

used for the purpose of reconstructing 

the ionizing radiation dose received by 

individuals or populations using 

physiological, chemical or biological 

markers of exposure found in humans. 

Radiation biodosimetry technologies 

may be used at various stages during 

triage and treatment after the exposure 

of a population to ionizing radiation as 

a result of intentional harm or as an 

unintended consequence of a disaster. 

Devices may be designed to give 

quantitative outputs or qualitative 

information around a clinical decision 

making cut-point. Likewise, devices 

may be designed for use in field triage 

settings, at patient bedsides, or in 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) (Pub. L. 

100–578) certified clinical laboratories. 

FDA considered both high-throughput 

and single-use devices in developing 

this draft guidance document. 

This draft guidance only applies to 

validation of biodosimetry devices 

intended to be used to assess exposure 

in non-therapeutic or accidental 

scenarios (e.g. a deliberate attack, such 

as use of an improvised nuclear device, 

or a natural disaster). This draft 

guidance neither applies to devices that 

assess deliberate radiation dosing that 

may occur in the course of medical 

treatment nor to devices that measure 

effects from long term exposure. In 

addition, dosimeters, which are devices 

that detect radiation exposure on a 

physical substrate rather than through a 

biological response and are worn by 

people who might be exposed to 

radiation during the course of their 

normal work (such as film badges), are 

not addressed in this guidance 

document. Finally, biological assays 

that might be used to detect the 

presence of ingested radioisotopes in 

sputum or urine are not considered in 

this draft guidance document. 

This draft guidance document does 

not provide specific study designs; it 

describes design principles for studies 

that may be used to establish the safety 

and effectiveness of radiation 

biodosimetry devices. 

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 evaluating the performance 

characteristics of radiation biodosimetry 

devices. 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 

Center 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 ‘‘Radiation Biodosimetry Devices’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1400045 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously 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 part 58 have 

been approved under OMB control 

number 0910–0119; 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 have 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 the 

guidance document entitled ‘‘Informed 

Consent For In Vitro Diagnostic Device 

Studies Using Leftover Human 

Specimens That Are Not Individually 

Identifiable’’ have been approved under 

OMB control number 0910–0582; and 

the collections of information in the 

guidance document entitled ‘‘Guidance 

for Industry and FDA Staff: 

Administrative Procedures for CLIA 

Categorization’’ have been approved 

under OMB control number 0910–0607. 

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: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30453 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Science Board to the Food and Drug 

Administration; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Science Board to 

the Food and Drug Administration 

(Science Board). 

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78450 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex scientific 

and technical issues important to the 

FDA and its mission, including 

emerging issues within the scientific 

community. Additionally, the Science 

Board provides advice to the Agency on 

keeping pace with technical and 

scientific developments including in 

regulatory science, input into the 

Agency’s research agenda, on upgrading 

its scientific and research facilities, and 

training opportunities. It will also 

provide, where requested, expert review 

of Agency-sponsored intramural and 

extramural scientific research programs. 

Date and Time: The meeting will be 

held on March 4, 2015, from 8:30 a.m. 

to 4 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503 B and C) Silver Spring, MD 

20993–0002. For those unable to attend 

in person, the meeting will also be 

Webcast. The link for the Webcast is 

available at https://

collaboration.fda.gov/sb315/. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Martha Monser, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 3309, 

Silver Spring, MD 20993–0002, 301– 

796–4627, martha.monser@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last minute modifications that 

impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

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

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: The Science Board will be 

provided with a progress report or a 

final draft report the Commissioner’s 

Fellowship Program Evaluation 

subcommittee and will hear a progress 

report from Science Moving Forward 

subcommittee. The Science Board will 

be asked to provide feedback on FDA’s 

public access policy. FDA will seek the 

Science Board’s input regarding 

approaches to regulatory science 

training coordination. The Science 

Board will be provided with a follow up 

on FDA’s activities regarding the reintroduction of bovine heparin and will 

hear an overview of science-related 

activities from one of the centers. A 

recipient of one of the Fiscal Year 2014 

Scientific Achievement Awards 

(selected by the Science Board) will 

provide an overview of the activities for 

which the award was given. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 25, 2015. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 1:30 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

17, 2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 18, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Ms. Martha 

Monser at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30516 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1936] 

Electronic Cigarettes and the Public 

Health; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Center for Tobacco Products, is 

announcing a public workshop to obtain 

information on electronic cigarettes and 

the public health. This will be the 

second in a series of three workshops. 

The workshop will include 

presentations and panel discussions 

about the current state of the science 

and will focus on individual health 

impacts. FDA intends to follow this 

workshop with an electronic cigarette 

workshop on population health effects. 

DATES AND TIMES: The public workshop 

will be held on March 9, 2015, from 8 

a.m. to 5 p.m. and on March 10, 2015, 

from 8 a.m. to 5 p.m. Individuals who 

wish to attend the public workshop 

must register by February 20, 2015. 

LOCATION: The public workshop will be 

held at the Marriott Inn and Conference 

Center, University of Maryland 

University College, Potomac Ballroom, 

3501 University Blvd. East, Hyattsville, 

MD 20783. The conference center’s 

telephone number is 301–985–7300. 

CONTACT PERSON: Caryn Cohen, Office of 

Science, Center for Tobacco Products, 

Food and Drug Administration, 

Document Control Center, Bldg. 71, Rm. 

mstockstill on DSK4VPTVN1PROD with NOTICES