Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8087 

Grantees submit semi-annual reports 

instead of quarterly report. This will 

reduce the administrative burden on 

Grantees, especially the smaller 

organizations. The majority of content 

being requested from the grantees 

essentially remain same except for the 

frequency of reporting. 

OPR: The following are proposed 

content changes to the document: 

Grantee Information: Report 

Frequency—This section of OPR will be 

reformatted to request semi-annual or 

final project data instead of quarterly 

information. The other sections of the 

document with reference to ‘‘quarterly’’ 

information will be changed to reflect 

the shift from four-times a year 

reporting requirement to twice per year. 

Objective Work Plan Update: Content 

remains the same. No changes are 

proposed for this section of the OPR. 

Impact indicator: Current Status of 

Expected Results and Current Status of 

Expected Benefits which are reported 

separately on the OPR will be combined 

to read ‘‘Current Status of Expected 

Results and Benefits.’’ The content 

requested in this section is similar to the 

previous OPR without the added burden 

of having the reporting organizations 

provide the analysis that distinguish 

between ‘results and benefits’’. Every 

section of the document will be 

rewritten to reflect this change. 

OWP: ANA proposes to reformat the 

OWP (content is same) by swapping the 

Objective field with Problem Statement. 

In other words, this section will require 

respondents to begin with a concise 

statement about the problem the project 

is designed to address and will be 

followed by more details about the 

objectives of the project. 

The two fields ‘‘Results Expected and 

Benefits Expected’’ will be combined 

into one field to read ‘‘Results and 

benefits Expected’’. This will reduce 

redundancy and help reduce the burden 

on Grantees. 

Respondents: Tribal Government, 

Native non-profit organizations, Tribal 

Colleges & Universities. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

OWP ................................................................................................................ 500 1 2 1000

OPR ................................................................................................................. 275 2 1 550

Estimated Total Annual Burden 

Hours: 1,550. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendation for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV, Attn: Desk Officer for 

the Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–03032 Filed 2–12–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

entitled ‘‘Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates ’’ that 

appeared in the Federal Register of 

February 6, 2015 (80 FR 6728). The 

document announced that a proposed 

collection of information has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995. The document 

was published with three errors. This 

document corrects those errors. 

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: In the 

Federal Register of Friday, February 6, 

2015, in FR Doc. 2015–02348, the 

following corrections are made: 

1. On page 6728, in the third column, 

under the heading Export of Food and 

Drug Administration Regulated 

Products: Export Certificates—(OMB 

Control Number 0910–0498)— 

Extension, the following sentence is 

added at the end of the first paragraph: 

‘‘In January 2011, section 801(e)(4)(A) 

was amended by the Food Safety 

Modernization Act (Pub. L. 111–353) to 

provide authorization for export 

certification fees for food and animal 

feed.’’ 

2. On page 6728, in the third column, 

under the heading Export of Food and 

Drug Administration Regulated 

Products: Export Certificates—(OMB 

Control Number 0910–0498)— 

Extension, in the second paragraph, the 

first sentence is revised to read as 

follows: ‘‘This section of the FD&C Act 

authorizes FDA to issue export 

certificates for regulated food, animal 

feed, pharmaceuticals, biologics, and 

devices that are legally marketed in the 

United States, as well as for these same 

products that are not legally marketed 

but are acceptable to the importing 

country, as specified in sections 801(e) 

and 802 of the FD&C Act.’’ 

3. On page 6729, Table 2 is corrected 

as follows: 


tkelley on DSK3SPTVN1PROD with NOTICES
8088 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

1On September 27, 2012, after Reckitt publicly 

announced that it was planning to discontinue the 

product, Lachman Consultant Services Inc. 

(Lachman) submitted a citizen petition requesting 

that the Agency determine whether SUBOXONE 

Sublingual Tablets were withdrawn from sale for 

reasons of safety or effectiveness (Docket No. FDA– 

2012–P–1034). After considering Lachman’s citizen 

petition and reviewing our records, including the 

analysis that the Agency prepared in connection 

with Reckitt’s citizen petition (Docket No. FDA– 

2012–P–1028), FDA determined that SUBOXONE 

Sublingual Tablets was not discontinued for 

reasons of safety or effectiveness (78 FR 34108). 

2On September 25, 2012, Reckitt submitted a 

citizen petition requesting that FDA not approve 

any new drug application or abbreviated new drug 

application (ANDA) for a buprenorphine product 

for treatment of opioid dependence unless the 

applications and products met certain criteria. On 

February 22, 2013, FDA denied Reckitt’s petition 

(Docket No. FDA–2012–P–1028). 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research ........................................ 2,114 1 2,114 1 2,114 

Center for Devices and Radiological Health ........................................... 10,528 1 10,528 2 21,056 

Center for Veterinary Medicine ................................................................ 1,848 1 1,848 1 1,848 

Total .................................................................................................. .................... .................... .................... .................... 25,018 

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

Dated: February 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03005 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–P–1055] 

Determination That SUBUTEX 

(Buprenorphine Hydrochloride) 

Sublingual Tablets, Equivalent 2 

Milligrams Base and Equivalent 8 

Milligrams Base, Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that SUBUTEX (buprenorphine 

hydrochloride (HCl)) Sublingual 

Tablets, Equivalent (Eq) 2 milligrams 

(mg) base and Eq 8 mg base, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to SUBUTEX, and it 

will allow FDA to continue to approve 

ANDAs that refer to SUBUTEX as long 

as they meet relevant legal and 

regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Ayako Sato, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6228, Silver Spring, 

MD 20993–0002, 240–402–4191. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA sponsors 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products with 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. 

SUBUTEX (buprenorphine HCl) 

Sublingual Tablets is the subject of NDA 

20–732, held by Reckitt Benckiser 

Pharmaceuticals, Inc. (Reckitt). It was 

approved on October 8, 2002. After 

Reckitt discontinued marketing 

SUBUTEX in 2011, FDA moved 

SUBUTEX to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. Another buprenorphinecontaining product, SUBOXONE 

(buprenorphine HCl and naloxone HCl) 

Sublingual Tablets, is the subject of 

NDA 20–733, also held by Reckitt. It 

was originally approved on October 8, 

2002, and later approved in another 

dosage form (sublingual film) on August 

30, 2010, under NDA 22–410. In March 

2013, Reckitt discontinued marketing 

the sublingual tablet dosage form of 

SUBOXONE.1 All three products are 

approved for treatment of opioid 

dependence.2

Actavis Elizabeth LLC submitted a 

citizen petition dated August 16, 2013 

(Docket No. FDA–2013–P–1055), under 

21 CFR 10.30, requesting that FDA 

determine whether SUBUTEX was 

withdrawn from sale for reasons of 

safety or effectiveness. The petition 

contains no data or other information 

suggesting that SUBUTEX was 

withdrawn for reasons of safety or 

effectiveness. 

We have carefully reviewed our 

records concerning the withdrawal of 

SUBUTEX from sale. Based on the 

information we have at this time, FDA 

has determined under § 314.161 that 

SUBUTEX was not withdrawn for 

reasons of safety or effectiveness. 

The buprenorphine in both SUBUTEX 

and SUBOXONE is a mu opioid partial 

agonist that can precipitate withdrawal 

in patients physically dependent on full 

opioid agonists. That is, the relative 

reduction in activity at the mu receptor 

when buprenorphine replaces a full 

opioid agonist can cause symptoms of 

opioid withdrawal. SUBOXONE also 

contains naloxone. Naloxone is a potent 


tkelley on DSK3SPTVN1PROD with NOTICES