Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78447 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0188. The 

approval expires on November 30, 2017. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30461 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–2007–D–0369] 

Draft and Revised Draft Guidances for 

Industry Describing Product-Specific 

Bioequivalence Recommendations; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of additional draft and 

revised draft product-specific 

bioequivalence (BE) recommendations. 

These recommendations provide 

product-specific guidance on the design 

of BE studies to support abbreviated 

new drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’, which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site. The BE 

recommendations identified in this 

notice were developed using the process 

described in that guidance. 

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 comments on these draft 

and revised draft guidances before it 

begins work on the final versions of the 

guidances, submit either electronic or 

written comments on the draft and 

revised draft product-specific BE 

recommendations listed in this notice 

by March 2, 2015. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances 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 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance 

recommendations. 

Submit electronic comments on the 

draft product-specific BE 

recommendations 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. 

FOR FURTHER INFORMATION CONTACT: Kris 

Andre Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4726, Silver Spring, 

MD 20993–0002, 240–402–7959. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

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

ComplianceRegulatoryInformation/

Guidances/default.htm. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific BE 

recommendations and to provide a 

meaningful opportunity for the public to 

consider and comment on those 

recommendations. Under that process, 

draft recommendations are posted on 

FDA’s Web site and announced 

periodically in the Federal Register. 

The public is encouraged to submit 

comments on those recommendations 

within 60 days of their announcement 

in the Federal Register. FDA considers 

any comments received, and either 

publishes final recommendations or 

publishes revised draft 

recommendations for comment. 

Recommendations were last announced 

in the Federal Register on April 2, 2014 

(79 FR 18561). This notice announces 

draft product-specific 

recommendations, either new or 

revised, that are posted on FDA’s Web 

site. 

II. Drug Products for Which New Draft 

Product-Specific BE Recommendations 

Are Available 

FDA is announcing the availability of 

a new draft guidance for industry on 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR

DRUG PRODUCTS

A ....... Acetaminophen; Aspirin; Caffeine. 

Acetaminophen; Butalbital; Caffeine; 

Codeine phosphate. 

Acyclovir. 

Aripiprazole. 

B ....... Benzyl alcohol. 

Betamethasone valerate. 

Bosutinib monohydrate. 

Brimonidine tartrate; Brinzolamide. 

Buprenorphine hydrochloride; 

Naloxone hydrochloride. 

C ....... Cobicistat; Elvitegravir; Emtricitabine; 

Tenofovir disoproxil fumarate. 

Conjugated estrogens. 

D ....... Dapsone. 

Darunavir ethanolate. 

I ........ Ibuprofen sodium. 

L ....... Levothyroxine sodium (multiple reference listed drugs). 

Lidocaine; Prilocaine. 

Lomitapide mesylate. 

Lurasidone hydrochloride. 

M ...... Metoprolol tartrate. 

N ....... Nepafenac (multiple reference listed 

drugs). 

P ....... Posaconazole. 

R ....... Raltegravir potassium. 

Regorafenib. 

S ....... Selegine hydrochloride. 

T ....... Testosterone. 

Tofacitinib citrate. 

Treprostinil. 

V ....... Vandetanib. 

III. Drug Products for Which Revised 

Draft Product-Specific BE 

Recommendations Are Available 

FDA is announcing the availability of 

a revised draft guidance for industry on 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS

FOR DRUG PRODUCTS

A ....... Adapalene (multiple reference listed 

drugs and dosage forms). 

Adapalene; Benzoyl peroxide. 

B ....... Brimonidine tartrate (multiple reference listed drugs). 

Brinzolamide. 

D ....... Doxorubicin hydrochloride. 

E ....... Ethinyl estradiol; Levonorgestrel. 

H ....... Hydrocodone bitartrate; Ibuprofen. 

K ....... Ketoconazole. 

M ...... Memantine hydrochloride (multiple 

dosage forms). 

Methylprednisolone acetate. 

N ....... Nebivolol hydrochloride. 

Nisoldipine. 

P ....... Phenytoin sodium (multiple reference 

listed drugs). 

S ....... Sevelamer carbonate. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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