78448 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS

FOR DRUG PRODUCTS—Continued 

Sevelamer hydrochloride. 

For a complete history of previously 

published Federal Register notices 

related to product-specific BE 

recommendations, please go to http://

www.regulations.gov and enter Docket 

No. FDA–2007–D–0369. 

These draft and revised draft 

guidances are being issued consistent 

with FDA’s good guidance practices 

regulation (21 CFR 10.115). These 

guidances represent the Agency’s 

current thinking on product-specific 

design of BE studies to support ANDAs. 

They do not create or confer any rights 

for or on any person and do 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. 

IV. Comments 

Interested persons may submit either 

electronic comments on any of the 

specific BE recommendations posted on 

FDA’s Web site 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. The 

guidances, notices, and 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30514 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] 

Advisory Committees; Filing of Closed 

Meeting Reports 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that, as required by the Federal 

Advisory Committee Act, the agency has 

filed with the Library of Congress the 

annual reports of those FDA advisory 

committees that held closed meetings 

during fiscal year 2014. 

ADDRESSES: Copies are available at the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, 240–402–7500. You also 

may access the docket at http://

www.regulations.gov for the annual 

reports of those FDA advisory 

committees that held closed meetings 

during fiscal year 2014. Insert the 

docket number found in brackets in the 

heading of this document at http://

www.regulations.gov into the ‘‘Search’’ 

box, clear filter under Document Type 

(left side of screen), and check 

‘‘Supporting and Related Material,’’ 

then Sort By Best Match (from the dropdown menu; top right side of screen), 

‘‘ID Number (Z–A)’’ or Sort By Best 

Match (from the drop-down menu) 

‘‘Title (A–Z),’’ also found in the heading 

of this document. 

FOR FURTHER INFORMATION CONTACT: 

Teresa L. Hays, Committee Management 

Officer, Advisory Committee and 

Oversight Management Staff, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–8220. 

SUPPLEMENTARY INFORMATION: Under 

section 10(d) of the Federal Advisory 

Committee Act (5 U.S.C. app.) and 21 

CFR 14.60(d), FDA has filed with the 

Library of Congress the annual reports 

for the following FDA advisory 

committees that held closed meetings 

during the period October 1, 2013, 

through September 30, 2014: 

Center for Biologics Evaluation and 

Research: 

Blood Products Advisory Committee 

Cellular, Tissue, and Gene Therapies 

Advisory Committee 

Vaccines and Related Biological 

Products Advisory Committee 

National Center for Toxicological 

Research: 

Science Board to the National Center for 

Toxicological Research 

Annual Reports are available for 

public inspections between 9 a.m. and 

4 p.m., Monday through Friday at the 

following locations: 

(1) The Library of Congress, Madison 

Bldg., Newspaper and Current 

Periodical Reading Room, 101 

Independence Ave. SE., Rm. 133, 

Washington, DC; and 

(2) The Dockets Management Branch 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30460 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–D–2065] 

Radiation Biodosimetry Devices; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Radiation Biodosimetry Devices.’’ 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. This 

draft guidance is not final nor is it in 

effect at this time. 

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 of 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 March 30, 

2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Radiation 

Biodosimetry Devices’’ to the Office of 

the Center Director, Guidance and 

Policy Development, Center for Devices 

mstockstill on DSK4VPTVN1PROD with NOTICES

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). 

mstockstill on DSK4VPTVN1PROD with NOTICES