78446 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Prominent and Conspicuous Mark of 

Manufacturers On Single-Use Devices— 

(OMB Control Number 0910–0577)— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements that the label 

or labeling of a medical device must 

meet so that it is not misbranded and 

subject to regulatory action. Section 301 

of the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250) amended section 502 of the FD&C 

Act to add section 502(u) to require 

devices (both new and reprocessed) to 

bear prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of the Medical Device 

User Fee Stabilization Act of 2005 (Pub. 

L. 109–43) amends section 502(u) of the 

FD&C Act by limiting the provision to 

reprocessed single-use devices (SUDs) 

and the manufacturers who reprocess 

them. Under the amended provision, if 

the original SUD or an attachment to it 

prominently and conspicuously bears 

the name of the manufacturer, then the 

reprocessor of the SUD is required to 

identify itself by name, abbreviation, or 

symbol in a prominent and conspicuous 

manner on the device or attachment to 

the device. If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. 

The requirements of section 502(u) of 

the FD&C Act impose a minimal burden 

on industry. This section of the FD&C 

Act only requires the manufacturer, 

packer, or distributor of a device to 

include their name and address on the 

labeling of a device. This information is 

readily available to the establishment 

and easily supplied. From its 

registration and premarket submission 

database, FDA estimates that there are 

67 establishments that distribute 

approximately 427 reprocessed SUDs. 

Each response is anticipated to take 0.1 

hours (6 minutes) resulting in a total 

burden to industry of 43 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Establishments listing less than 10 

SUDs.

58 2 116 0.1 (6 minutes) ................................. 12 

Establishments listing 10 or more 

SUDs.

9 34 306 0.1 (6 minutes) ................................. 31 

Total ........................................... ........................ ........................ ........................ ........................................................... 43 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Numbers have been rounded. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30511 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–1027] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Infant Formula Recall Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Infant Formula Recall Regulations’’ 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 27, 2014, the Agency submitted 

a proposed collection of information 

entitled ‘‘Infant Formula Recall 

Regulations’’ 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

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