Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4913 

Printing Office, HHS, and other agencies 

on matters pertaining to print and 

publication procurement; (6) analyzes 

and reports CDC–INFO data to inform 

communication planning and programs 

throughout the agency; and (7) provides 

writer-editor support for the Office of 

the Director. 

Sherri A. Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2016–01676 Filed 1–27–16; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Bioequivalence 

Recommendations; Draft and Revised 

Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific bioequivalence (BE) 

recommendations. The 

recommendations provide productspecific 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’’ that 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 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on the draft guidance by March 28, 

2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Product-Specific 

Bioequivalence Recommendations; Draft 

and Revised Draft Guidances for 

Industry.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions: To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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– 

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 document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4730, 

Silver Spring, MD 20993–0002, 301– 

796–5850. 

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’’ that 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


wgreen on DSK2VPTVN1PROD with NOTICES
4914 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 

ComplianceRegulatoryInformation/

Guidances/default.htm. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

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 September 

21, 2015 (80 FR 57000). 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 

new draft guidances 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

Alprostadil. 

Atazanavir sulfate; cobicistat. 

Beclomethasone dipropionate. 

Betamethasone dipropionate. 

Betamethasone valerate. 

Betaxolol hydrochloride. 

Ciclesonide. 

Clobetasol propionate. 

Desonide (multiple reference listed drugs). 

Diflorasone diacetate (multiple reference listed drugs). 

Difluprednate emulsion. 

Elvitegravir. 

Erythromycin. 

Ethinyl estradiol; norethindrone acetate. 

Flurandrenolide. 

Formoterol fumarate; mometasone furoate. 

Ingenol mebutate (multiple strengths). 

Mercaptopurine. 

Methylphenidate hydrocholoride. 

Metronidazole. 

Mometasone furoate. 

Naftifine hydrochloride (multiple reference 

listed drugs). 

Nicotine. 

Olanzapine pamoate. 

Omega-3-carboxylic acids. 

Prednisone. 

Ranitidine hydrochloride. 

Riociguat. 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR

DRUG PRODUCTS—Continued 

Spinosad. 

Trametinib dimethyl sulfoxide. 

Vorapaxar sulfate. 

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

Abiraterone acetate. 

Amphotericin B. 

Ciprofloxacin hydrochloride; hydrocortisone. 

Colesevelam hydrochloride. 

Drospirenone; estradiol. 

Guanfacine hydrochloride. 

Lidocaine. 

Lomitapide mesylate. 

Methylphenidate hydrochloride. 

Phytonadione. 

Rivastigmine tartrate. 

For a complete history of previously 

published Federal Register notices 

related to product-specific BE 

recommendations, go to http://

www.regulations.gov and enter Docket 

No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on the product-specific 

design of BE studies to support ANDAs. 

They do not establish any rights for any 

person and are not binding on FDA or 

the public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: January 22, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01682 Filed 1–27–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0438] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use’’ has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

October 8, 2015, the Agency submitted 

a proposed collection of information 

entitled ‘‘Early Food Safety Evaluation 

of New Non-Pesticidal Proteins 

Produced by New Plant Varieties 

Intended for Food Use’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0583. The approval expires on 

November 30, 2018. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: January 22, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01686 Filed 1–27–16; 8:45 am] 

BILLING CODE 4164–01–P 


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