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a revised draft guidance for industry on 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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