2456 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL—Continued 

Application No. Drug Applicant 

ANDA 075375 .......... Diltiazem Hydrochloride (HCl) Injection, 5 mg/milliliter (mL) Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 

781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, 

WV 26504. 

ANDA 076911 .......... Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, 

and 15 mg.

Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, 

NJ 08540. 

ANDA 077102 .......... Calcitriol Injection, 0.001 mg/mL ........................................... Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite 

450, Schaumburg, IL 60195. 

ANDA 084656 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, 

OH 43228. 

ANDA 087977 .......... Diphenhydramine HCl Capsules, 25 mg .............................. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 

11788. 

ANDA 088676 .......... Methylprednisolone Sodium Succinate for Injection USP, 

Equivalent to 40 mg base/vial.

LyphoMed, Division of Fujisawa USA, Inc., 2045 North 

Cornell Ave., Melrose Park, IL 60160. 

ANDA 089080 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, 

NJ 07207. 

ANDA 089183 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

Superpharm Corp., 1769 Fifth Ave., Bayshore, NY 11706. 

ANDA 089253 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Do. 

ANDA 089219 .......... Procainamide HCl Capsules USP, 250 mg, 375 mg, and 

500 mg.

IDT Australia, Ltd., c/o Facet Life Sciences, Inc., 6122 

Stone Wolfe Dr., Glen Carbon, IL 62034. 

ANDA 089254 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Do. 

ANDA 089369 .......... Procainamide HCl Extended-Release Tablets USP, 250 

mg, 500 mg, and 750 mg.

Do. 

ANDA 089481 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

American Therapeutics, Inc., 75 Carlough Rd., Bohemia, 

NY 11716. 

ANDA 089482 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Do. 

ANDA 089483 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Do. 

ANDA 206711 .......... Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 

mg, and 20 mg.

Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., One 

Grande Commons, 440 U.S. Highway 22 East, Suite 

150, Bridgewater, NJ 08807. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 16, 

2018. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in table 1 

that are in inventory on the date that 

this notice becomes effective (see the 

DATES section) may continue to be 

dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00695 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0155] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency or we) 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 

collection provisions of our veterinary 

feed directive (VFD) regulation. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 19, 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 March 19, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 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 


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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2457 

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– 

2010–N–0155 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Veterinary Feed Directive.’’ 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 office 

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- 

23389.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. 

Veterinary Feed Directive—21 CFR 

558.6 

OMB Control Number 0910–0363— 

Extension 

Section 504 of the Federal Food, Drug, 

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

U.S.C. 354) establishes a regulatory 

category for certain new animal drugs 

called VFD drugs. Our VFD regulation is 

set forth at § 558.6 (21 CFR 558.6). VFD 

drugs are new animal drugs intended for 

use in or on animal feed which are 

limited to use under the professional 

supervision of a licensed veterinarian in 

the course of the veterinarian’s 

professional practice (§ 558.3 (21 CFR 

558.3(b)(6))). An animal feed containing 

a VFD drug or a combination VFD drug 

may be fed to animals only by or upon 

a lawful VFD issued by a licensed 

veterinarian (§ 558.6(a)(1)). 

Veterinarians issue three copies of the 

VFD: one for their own records, one for 

their client, and one to the client’s VFD 

feed distributor (§§ 558.6(a)(4) and 

558.6(b)(8)–(9)). The VFD includes 

information about the number and 

species of animals to receive feed 

containing one or more of the VFD 

drugs (§ 558.6(b)(3)), along with other 

information required under § 558.6. All 

distributors of medicated feed 

containing VFD drugs must notify us of 

their intent to distribute such feed and 

must maintain records of the receipt and 

distribution of all medicated feeds 

containing VFD drugs. 

The VFD regulation ensures the 

protection of public health while 

enabling animal producers to obtain and 

use needed drugs as efficiently and costeffectively as possible. The VFD 

regulation is tailored to the unique 

circumstances relating to the 

distribution and use of animal feeds 

containing a VFD drug. 

We will use the information collected 

to assess compliance with the VFD 

regulation. The required recordkeeping 

and third party disclosures provide 

assurance that the medicated feeds will 

be safe and effective for their labeled 

conditions of use and that edible 


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products from treated animals will be 

free of unsafe drug residues. 

We estimate the burden of this 

collection of information as follows. We 

base our estimates on our analysis of the 

information collection provisions of the 

final rule entitled ‘‘Veterinary Feed 

Directive,’’ published in the Federal 

Register of June 3, 2015 (80 FR 31708 

at 31728) (the June 3, 2015, final rule). 

A. Reporting Requirements 

Description of Respondents: VFD 

Feed Distributors, VFD Drug Sponsors. 

A distributor of animal feed 

containing a VFD drug must notify us 

prior to the first time it distributes the 

VFD feed (§ 558.6(c)(5)). This 

notification is required one time per 

distributor and must include the 

information set forth in § 558.6(c)(5). In 

addition, a distributor must notify us 

within 30 days of any change in 

ownership, business name, or business 

address (§ 558.6(c)(6)). Additional 

reporting burdens for current VFD drug 

sponsors are approved under OMB 

control numbers 0910–0032 (New 

Animal Drug Applications) and 0910– 

0669 (Abbreviated New Animal Drug 

Applications). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section, activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses Average burden per response Total hours 

558.6(c)(5); requires a distributor to 

notify us prior to the first time it 

distributes a VFD feed.

300 1 300 .125 (7 minutes) ............................... 37.5 

558.6(c)(6); requires a distributor to 

notify us within 30 days of any 

change in ownership, business 

name, or business address.

20 1 20 .125 (7 minutes) ............................... 2.5 

Total ........................................... ........................ ........................ ........................ ........................................................... 40 

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

B. Recordkeeping Requirements 

Description of Respondents: VFD 

Feed Distributors, Food Animal 

Veterinarians, and Clients (Food Animal 

Producers). 

As stated previously, veterinarians 

issue three copies of the VFD: One for 

their own records, one for their client, 

and one to the client’s VFD feed 

distributor. All involved parties (the 

veterinarian, the distributor, and the 

client) must retain a copy of the VFD for 

2 years (§ 558.6(a)(4)). In addition, VFD 

feed distributors must also keep receipt 

and distribution records of VFD feeds 

they manufacture and make them 

available for inspection by us for 2 years 

(§ 558.6(c)(3)). 

If a distributor manufactures the VFD 

feed, the distributor must also keep VFD 

manufacturing records for 1 year in 

accordance with 21 CFR part 225 and 

such records must be made available for 

inspection and copying by FDA upon 

request (§ 558.6(c)(4)). These record 

requirements are currently approved 

under OMB control number 0910–0152, 

‘‘Current Good Manufacturing Practice 

Regulations for Medicated Feed.’’ 

Distributors may distribute VFD to 

another distributor only if the 

originating distributor first obtains a 

written acknowledgement letter. Such 

letters, like VFDs, are also subject to a 

2-year record retention requirement 

(§ 558.6(c)(8)). 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section, activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

558.6(a)(4); required recordkeeping 

by veterinarians and producers.

13,050 114.9 1,500,000 .0167 (1 minute) ............................... 25,050 

558.6(a)(4), (c)(3)–(4), and (c)(8); required recordkeeping by distributors.1,376 545.1 750,000 .0167 (1 minute) ............................... 12,525 

Total ........................................... ........................ ........................ ........................ ........................................................... 37,575 

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

C. Third-Party Disclosure Requirements 

Description of Respondents: VFD 

Drug Sponsors, Food Animal 

Veterinarians, VFD Feed Distributors, 

and Clients. 

Our regulation requires that 

veterinarians include the information 

specified at § 558.6(b)(3) through (5) on 

the VFD. Additional requirements 

relating to the VFD are specified at 

§ 558.6(b)(7) through (9). A distributor 

may only distribute a VFD feed to 

another distributor for further 

distribution if the originating distributor 

(consignor) first obtains a written 

acknowledgement letter from the 

receiving distributor (consignee) before 

the feed is shipped (§ 558.6(c)(8)). 


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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2459 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section, activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures Average burden per disclosure Total hours 

558.6(b)(3)–(5) and (b)(7)-(9); required disclosures when a veterinarian issues a VFD.3,050 246 750,000 .125 (7 minutes) ............................... 93,750 

558.6(c)(8); required disclosure (acknowledgement letter) from one 

distributor to another.

1,000 5 5,000 .125 (7 minutes) ............................... 625 

Total ........................................... ........................ ........................ ........................ ........................................................... 94,375 

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

The VFD regulation also contains 

several labeling provisions that are 

exempt from OMB review and approval 

under the PRA because they are a 

‘‘public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)) and therefore do not 

constitute a ‘‘collection of information’’ 

under the PRA (44 U.S.C. 3501, et seq.). 

All labeling and advertising for VFD 

drugs, combination VFD drugs, and 

feeds containing VFD drugs or 

combination VFD drugs must 

prominently and conspicuously display 

the following cautionary statement: 

‘‘Caution: Federal law restricts 

medicated feed containing this 

veterinary feed directive (VFD) drug to 

use by or on the order of a licensed 

veterinarian’’ (§ 558.6(a)(6)). In addition, 

the veterinarian must ensure that the 

following statement is included on the 

VFD (§ 558.6(b)(3)(xiii)): ‘‘Use of feed 

containing this veterinary feed directive 

(VFD) drug in a manner other than as 

directed on the labeling (extralabel use) 

is not permitted.’’ 

The veterinarian may restrict VFD 

authorization to only include the VFD 

drug(s) cited on the VFD or such 

authorization may be expanded to allow 

the use of the cited VFD drug(s) along 

with one or more over-the-counter 

animal drugs in an approved, 

conditionally approved, or indexed 

combination VFD drug (§ 558.6(b)(6)). 

The veterinarian must affirm his or her 

intent regarding combination VFD drugs 

by including one of the following 

statements on the VFD: 

1. ‘‘This VFD only authorizes the use 

of the VFD drug(s) cited in this order 

and is not intended to authorize the use 

of such drug(s) in combination with any 

other animal drugs’’ (§ 558.6(b)(6)(i)). 

2. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in the 

following FDA-approved, conditionally 

approved, or indexed combination(s) in 

medicated feed that contains the VFD 

drug(s) as a component.’’ (List specific 

approved, conditionally approved, or 

indexed combination medicated feeds 

following this statement. 

§ 558.6(b)(6)(ii).) 

3. ‘‘This VFD authorizes the use of the 

VFD drug(s) cited in this order in any 

FDA-approved, conditionally approved, 

or indexed combination(s) in medicated 

feed that contains the VFD drug(s) as a 

component’’ (§ 558.6(b)(6)(iii)). 

These labeling statements are not 

subject to review by OMB because, as 

stated previously, they are a ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)) and therefore do not 

constitute a ‘‘collection of information’’ 

under the PRA (44 U.S.C. 3501, et seq.). 

Our estimate of the annual burden for 

this information collection has not 

changed since the last OMB approval, 

which was associated with the June 3, 

2015, final rule. However, the one-time 

burdens that we included in our 

analysis of the June 3, 2015, final rule 

(80 FR 31708 at 31729 to 31732) are not 

included in our current estimate. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00676 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–3619] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AXUMIN 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for AXUMIN and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 19, 2018. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

July 16, 2018. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 March 19, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 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://


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