Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51279 

We invite 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. 

Title: Controlled Correspondence 

Related to Generic Drug Development— 

OMB Control Number 0910–0797— 

Revision. 

Description: FDA has agreed to 

specific program enhancements and 

performance goals specified in the 

GDUFA II Commitment Letter. One of 

the performance goals applies to 

controlled correspondence related to 

generic drug development. The GDUFA 

II Commitment Letter includes details 

on FDA’s commitment to respond to 

questions submitted as controlled 

correspondence within certain time 

frames. To facilitate FDA’s prompt 

consideration of the controlled 

correspondence and to assist in meeting 

the prescribed time frames, FDA 

recommends including the following 

information in the inquiry: (1) Name, 

title, address, phone number, and entity 

of the person submitting the inquiry; (2) 

a letter of authorization, if applicable; 

(3) the FDA-assigned control number 

and submission date of any previous, 

related controlled correspondence that 

was accepted for substantial review and 

response, if any, as well as a copy of 

that previous controlled correspondence 

and FDA’s response, if any; (4) the 

relevant reference listed drug(s), as 

applicable, including the application 

number, proprietary (brand) name, 

manufacturer, active ingredient, dosage 

form, and strength(s); (5) a statement 

that the controlled correspondence is 

related to a potential abbreviated new 

drug application (ANDA) submission to 

the Office of Generic Drugs, and the 

ANDA number, if applicable; (6) a 

concise statement of the inquiry; (7) a 

recommendation of the appropriate FDA 

review discipline; and (8) relevant prior 

research and supporting materials. 

The GDUFA II Commitment Letter 

also includes details on FDA’s 

commitment to respond to requests to 

clarify ambiguities in FDA’s controlled 

correspondence response within certain 

time frames. To facilitate FDA’s prompt 

consideration of the request, and to 

assist in meeting the prescribed time 

frames, FDA recommends including the 

following information in the inquiry: (1) 

Name, title, address, phone number, and 

entity of the person submitting the 

inquiry; (2) a letter of authorization, if 

applicable; (3) the FDA-assigned control 

number, submission date of the 

controlled correspondence on which the 

requestor is seeking clarification, a copy 

of that previous controlled 

correspondence, and FDA’s response to 

the controlled correspondence; and (4) 

the clarifying questions and the 

corresponding section(s) of FDA’s 

controlled correspondence response on 

which the requestor is seeking 

clarification. 

The following information is based on 

inquiries considered controlled 

correspondence and submitted to FDA 

for fiscal years 2014, 2015, and 2016. 

FDA estimates approximately 390 

generic drug manufacturers and related 

industry (e.g., contract research 

organizations conducting bioanalytical 

or bioequivalence clinical trials) or their 

representatives would each submit an 

average of 3.8 inquiries annually for a 

total of 1,496 inquiries [1,496 ÷ 390 = 

3.8]. Information submitted with each 

inquiry varies widely in content, 

depending on the complexity of the 

request. Inquiries that are defined as 

controlled correspondence may range 

from a simple inquiry on generic drug 

labeling to a more complex inquiry for 

a formulation assessment for a specific 

proposed generic drug product. As a 

result, these inquiries can vary between 

1 to 10 burden hours, respectively. 

Because the content of inquiries 

considered controlled correspondence is 

widely varied, we are providing an 

average burden hour for each inquiry. 

We estimate that it will take an average 

of 5 hours per inquiry for industry to 

gather necessary information, prepare 

the request, and submit the request to 

FDA. As a result, we estimate that it will 

take an average of 7,480 total hours 

annually for industry to prepare and 

submit inquiries considered controlled 

correspondence. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Submission of controlled correspondence Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Generic drug manufacturers, related industry, and representatives ...................................................................... 390 3.8 1,496 5 7,480 

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

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https:// 

www.regulations.gov. 

Dated: October 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23947 Filed 11–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0510] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 


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51280 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 

collection provisions of existing FDA 

regulations concerning substances 

prohibited for use in animal food or 

feed. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 2, 2018. 

ADDRESSES: You may submit comments 

as follows: Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 2, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 2, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2011–N–0510 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Substances Prohibited From Use in 

Animal Food or Feed.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov

/fdsys/pkg/FR-2015-09-18/pdf/2015-233

89.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

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. 

Substances Prohibited From Use in 

Animal Food or Feed—21 CFR 

589.2001 

OMB Control Number 0910–0627— 

Extension 

This information collection supports 

Agency regulations regarding substances 

prohibited from use in animal food or 

feed. Bovine spongiform 

encephalopathy (BSE) is a progressive 

and fatal neurological disorder of cattle 

that results from an unconventional 

transmissible agent. BSE belongs to the 

family of diseases known as 

transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. Our regulation at 

§ 589.2001 (21 CFR 589.2001) entitled, 


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Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51281 

‘‘Cattle materials prohibited in animal 

food or feed to prevent the transmission 

of bovine spongiform encephalopathy’’ 

is designed to further strengthen 

existing safeguards against the 

establishment and amplification of BSE 

in the United States through animal 

feed. The regulation prohibits the use of 

certain cattle origin materials in the 

food or feed of all animals. These 

materials are referred to as ‘‘cattle 

materials prohibited in animal feed’’ or 

CMPAF. Under § 589.2001, no animal 

feed or feed ingredient can contain 

CMPAF. As a result, we impose 

requirements on renderers of 

specifically defined cattle materials, 

including reporting and recordkeeping 

requirements. For purposes of the 

regulation, we define a renderer as any 

firm or individual that processes 

slaughter byproducts, animals unfit for 

human consumption, including 

carcasses of dead cattle, or meat scraps. 

Reporting and recordkeeping 

requirements are necessary because 

once materials are separated from an 

animal it may not be possible, without 

records, to know whether the cattle 

material meets the requirements of our 

regulation. 

Recordkeeping: Renderers that 

receive, manufacture, process, blend, or 

distribute CMPAF, or products that 

contain or may contain CMPAF, must 

take measures to ensure that the 

materials are not introduced into animal 

feed, including maintaining adequate 

written procedures specifying how such 

processes are to be carried out 

§ 589.2001(c)(2)(ii)). Renderers that 

receive, manufacture, process, blend, or 

distribute CMPAF, are required to 

establish and maintain records 

sufficient to track the CMPAF to ensure 

that they are not introduced into animal 

feed (§ 589.2001(c)(2)(vi)). 

Renderers that receive, manufacture, 

process, blend, or distribute any cattle 

materials must establish and maintain 

records sufficient to demonstrate that 

material rendered for use in animal feed 

was not manufactured from, processed 

with, or does not otherwise contain, 

CMPAF (§ 589.2001(c)(3)(i)). 

Renderers that receive, manufacture, 

process, blend, or distribute any cattle 

materials must, if these materials were 

obtained from an establishment that 

segregates CMPAF from other materials, 

establish and maintain records to 

demonstrate that the supplier has 

adequate procedures in place to 

effectively exclude CMPAF from any 

materials supplied (§ 589.2001(c)(3)(i)). 

Records will meet this requirement if 

they include either: (1) Certification or 

other documentation from the supplier 

that materials supplied do not include 

CMPAF (§ 589.2001(c)(3)(i)(A)) or (2) 

documentation of another method 

acceptable to FDA, such as third-party 

certification (§ 589.2001(c)(3)(i)(B)). 

Reporting: Under our regulations, we 

may designate a country from which 

cattle materials are not considered 

CMPAF. Section 589.2001(f) provides 

that a country seeking to be so 

designated must send a written request 

to the Director of the Center for 

Veterinary Medicine. The information 

the country is required to submit 

includes information about that 

country’s BSE case history, risk factors, 

measures to prevent the introduction 

and transmission of BSE, and any other 

information relevant to determining 

whether the cattle materials from the 

requesting country do or do not meet 

the definitions set forth in 

§ 589.2001(b)(1). We use the information 

to determine whether to grant a request 

for designation and to impose 

conditions if a request is granted. 

Section 589.2001(f) further states that 

countries designated under that section 

will be subject to our future review to 

determine whether their designations 

remain appropriate. As part of this 

process, we may ask designated 

countries from time to time to confirm 

that their BSE situation and the 

information submitted by them in 

support of their original application 

remains unchanged. We may revoke a 

country’s designation if we determine 

that it is no longer appropriate. 

Therefore, designated countries may 

respond to our periodic requests by 

submitting information to confirm their 

designations remain appropriate. We 

use the information to ensure their 

designations remain appropriate. 

Description of Respondents: 

Respondents to this information 

collection include rendering facilities, 

feed manufacturers, livestock feeders, 

and foreign governments seeking 

designation under § 589.2001(f). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

589.2001(c)(2)(ii), maintain written procedures ................. 50 1 50 20 1,000 

589.2001(c)(2)(vi) and (c)(3)(i), maintain records ............. 175 1 175 20 3,500 

589.2001(c)(3)(i)(A) and (B), certification or documentation from the supplier ..................................................... 175 1 175 26 4,550 

Total ............................................................................ .......................... ........................ ........................ ........................ 9,050 

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

Except where otherwise noted, this 

estimate is based on our estimate of the 

number of facilities affected by the final 

rule entitled, ‘‘Substances Prohibited 

From Use in Animal Food or Feed’’, 

published in the Federal Register of 

April 25, 2008 (73 FR 22720 at 22753). 

The estimated recordkeeping burden is 

derived from Agency resources and 

discussions with affected industry. Our 

regulations require the maintenance of 

certain written procedures if cattle not 

inspected and passed for human 

consumption are to be rendered for use 

in animal feed. The recordkeeping 

burden associated with the requirement 

to maintain written procedures 

(§ 589.2001(c)(2)(ii)) will apply to only 

those renderers that choose to render for 

use in animal feed cattle not inspected 

and passed for human consumption. 

The recordkeeping requirement in 

§ 589.2001(c)(2)(vi) will apply to the 

limited number of renderers that will 

handle CMPAF. We estimate that the 

recordkeeping burden associated with 

§ 589.2001(c)(3)(i) would apply to the 

balance of the rendering firms not 

handling CMPAF. Table 1 also reflects 

the estimated 26 hours each renderer 

will need to satisfy the requirement in 

§ 589.2001(c)(3)(i)(A) and (B) under 

which renderers must maintain records 

from their supplier, certifying that 

materials provided were free of CMPAF. 


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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

589.2001(f); request for designation .................................... 1 1 1 80 80 

589.2001(f); response to request for review by FDA .......... 1 1 1 26 26 

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

Our estimate of the reporting burden 

for designation under § 589.2001(f) is 

based on estimates in the final rule 

entitled, ‘‘Substances Prohibited From 

Use in Animal Food or Feed,’’ 

published in the Federal Register of 

April 25, 2008, our experience, and the 

average number of requests for 

designation received in the past 3 years. 

The reporting burden for § 589.2001(f) is 

minimal because requests for 

designation are seldom submitted. Since 

2009, we have received two requests for 

designation. In the last 3 years, we have 

not received any new requests for 

designation; therefore, we estimate that 

one or fewer requests for designation 

will be submitted annually. Although 

we have not received any new requests 

for designation in the last 3 years, we 

believe these information collection 

provisions should be extended to 

provide for the potential future need of 

a foreign government to request 

designation under § 589.2001(f). Table 

2, row 1 presents the expected burden 

of requests for designation. Countries 

designated under § 589.2001(f) are 

subject to review by FDA to ensure that 

their designation remains appropriate. 

We assume a country’s response to a 

request for review will take about one 

third the time and effort of a request for 

designation. Table 2, row 2 presents the 

expected burden of a request for review. 

The burden for this information 

collection has not changed since the last 

OMB approval. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23948 Filed 11–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–2044] 

Determination That REVEX (Nalmefene 

Hydrochloride Injection), 0.1 Milligram 

Base/Milliliter and 1.0 Milligram Base/ 

Milliliter, Was 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 or Agency) has 

determined that REVEX (nalmefene 

hydrochloride injection), 0.1 milligram 

(mg) base/milliliter (mL) and 1.0 mg 

base/mL, was not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for REVEX 

(nalmefene hydrochloride injection), 0.1 

mg base/mL and 1.0 mg base/mL, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Kelley Nduom, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6221, 

Silver Spring, MD 20993–0002, 301– 

796–8597. 

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 applicants 

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. ANDA applicants 

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). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

REVEX (nalmefene hydrochloride 

injection), 0.1 mg base/mL and 1.0 mg 

base/mL, is the subject of NDA 20–459, 

currently held by West-Ward 

Pharmaceuticals International Limited, 

and initially approved on April 17, 

1995. REVEX is indicated for the 

complete or partial reversal of opioid 

drug effects, including respiratory 

depression, induced by either natural or 

synthetic opioids. REVEX is also 

indicated in the management of known 

or suspected opioid overdose. 

In a letter dated June 5, 2009, Baxter 

Healthcare Corporation, the NDA holder 

at the time, notified FDA that the 

manufacturing and distribution of 

REVEX (nalmefene hydrochloride 

injection), 0.1 mg base/mL and 1.0 mg 

base/mL, had been discontinued on May 

21, 2008, for business reasons. REVEX 

(nalmefene hydrochloride injection), 0.1 

mg base/mL and 1.0 mg base/mL, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Nirsum Pharmaceuticals, LLC, 

submitted a citizen petition dated 

March 31, 2017 (Docket No. FDA–2017– 


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