81 FR 4914 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range		4914-4914
FR Document		2016-01686

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.

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016)

[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Page 4914]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01686]


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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

4914 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices

ComplianceRegulatoryInformation/ TABLE 1—NEW DRAFT PRODUCT-SPE- DEPARTMENT OF HEALTH AND
Guidances/default.htm. CIFIC BE RECOMMENDATIONS FOR HUMAN SERVICES
As described in that guidance, FDA DRUG PRODUCTS—Continued
adopted this process as a means to Food and Drug Administration
develop and disseminate product- Spinosad.
specific BE recommendations and Trametinib dimethyl sulfoxide. [Docket No. FDA–2012–N–0438]
provide a meaningful opportunity for Vorapaxar sulfate.
the public to consider and comment on Agency Information Collection
those recommendations. Under that III. Drug Products for Which Revised Activities; Announcement of Office of
process, draft recommendations are Draft Product-Specific BE Management and Budget Approval;
posted on FDA’s Web site and Recommendations are Available Early Food Safety Evaluation of New
announced periodically in the Federal Non-Pesticidal Proteins Produced by
Register. The public is encouraged to FDA is announcing the availability of
a revised draft guidance for industry on New Plant Varieties Intended for Food
submit comments on those Use
recommendations within 60 days of product-specific BE recommendations
their announcement in the Federal for drug products containing the
AGENCY: Food and Drug Administration,
Register. FDA considers any comments following active ingredients:
HHS.
received and either publishes final
recommendations or publishes revised TABLE 2—REVISED DRAFT PRODUCT- ACTION: Notice.
draft recommendations for comment. SPECIFIC BE RECOMMENDATIONS
Recommendations were last announced FOR DRUG PRODUCTS SUMMARY: The Food and Drug
in the Federal Register on September Administration (FDA) is announcing
21, 2015 (80 FR 57000). This notice Abiraterone acetate. that a collection of information entitled
announces draft product-specific Amphotericin B. ‘‘Early Food Safety Evaluation of New
recommendations, either new or Ciprofloxacin hydrochloride; hydrocortisone. Non-Pesticidal Proteins Produced by
revised, that are posted on FDA’s Web Colesevelam hydrochloride. New Plant Varieties Intended for Food
site. Drospirenone; estradiol. Use’’ has been approved by the Office of
Guanfacine hydrochloride. Management and Budget (OMB) under
II. Drug Products for Which New Draft
Lidocaine. the Paperwork Reduction Act of 1995.
Product-Specific BE Recommendations
Lomitapide mesylate.
are Available FOR FURTHER INFORMATION CONTACT: FDA
Methylphenidate hydrochloride.
FDA is announcing the availability of Phytonadione. PRA Staff, Office of Operations, Food
new draft guidances for industry on Rivastigmine tartrate. and Drug Administration, 8455
product-specific BE recommendations Colesville Rd., COLE–14526, Silver
for drug products containing the For a complete history of previously Spring, MD 20993–0002,
following active ingredients: published Federal Register notices PRAStaff@fda.hhs.gov.
related to product-specific BE
TABLE 1—NEW DRAFT PRODUCT-SPE- recommendations, go to http:// SUPPLEMENTARY INFORMATION: On
CIFIC BE RECOMMENDATIONS FOR www.regulations.gov and enter Docket October 8, 2015, the Agency submitted
DRUG PRODUCTS a proposed collection of information
No. FDA–2007–D–0369.
entitled ‘‘Early Food Safety Evaluation
Alprostadil.
These draft guidances are being of New Non-Pesticidal Proteins
Atazanavir sulfate; cobicistat. issued consistent with FDA’s good Produced by New Plant Varieties
Beclomethasone dipropionate. guidance practices regulation (21 CFR Intended for Food Use’’ to OMB for
Betamethasone dipropionate. 10.115). These draft guidances, when review and clearance under 44 U.S.C.
Betamethasone valerate. finalized, will represent the current 3507. An Agency may not conduct or
Betaxolol hydrochloride. thinking of FDA on the product-specific
Ciclesonide. sponsor, and a person is not required to
design of BE studies to support ANDAs.
Clobetasol propionate. respond to, a collection of information
They do not establish any rights for any
Desonide (multiple reference listed drugs). unless it displays a currently valid OMB
person and are not binding on FDA or
Diflorasone diacetate (multiple reference list- control number. OMB has now
ed drugs). the public. You can use an alternative
approved the information collection and
Difluprednate emulsion. approach if it satisfies the requirements
of the applicable statutes and has assigned OMB control number
Elvitegravir.
Erythromycin. regulations. 0910–0583. The approval expires on
Ethinyl estradiol; norethindrone acetate. November 30, 2018. A copy of the
Flurandrenolide. II. Electronic Access supporting statement for this
Formoterol fumarate; mometasone furoate. information collection is available on
Ingenol mebutate (multiple strengths). Persons with access to the Internet
the Internet at http://www.reginfo.gov/
Mercaptopurine. may obtain the draft guidance at either
public/do/PRAMain.
Methylphenidate hydrocholoride. http://www.fda.gov/Drugs/Guidance
Metronidazole. ComplianceRegulatoryInformation/ Dated: January 22, 2016.
Mometasone furoate. Guidances/default.htm or http:// Leslie Kux,
wgreen on DSK2VPTVN1PROD with NOTICES

Naftifine hydrochloride (multiple reference www.regulations.gov. Associate Commissioner for Policy.
listed drugs).
Nicotine. Dated: January 22, 2016. [FR Doc. 2016–01686 Filed 1–27–16; 8:45 am]
Olanzapine pamoate. Leslie Kux, BILLING CODE 4164–01–P
Omega-3-carboxylic acids. Associate Commissioner for Policy.
Prednisone.
Ranitidine hydrochloride. [FR Doc. 2016–01682 Filed 1–27–16; 8:45 am]
Riociguat. BILLING CODE 4164–01–P

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Document Created: 2018-02-02 12:41:03
Document Modified: 2018-02-02 12:41:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 4914

81 FR 4914 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration