Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 27009 

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)–(b)(5) and (b)(7)–(b)(9); required disclosures when a veterinarian issues a VFD.3,050 246 750,000 0.125 (7 minutes) ...... 93,750 

558.6(c)(8); required disclosure (acknowledgement 

letter) from one distributor to another.

1,000 5 5,000 0.125 (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.). 

The one-time burdens included in 

FDA’s analysis of the June 3, 2015, final 

rule (80 FR 31708 at 31729 to 31732) are 

not included in the estimate provided in 

this notice. FDA’s estimate of the annual 

recurring burden for this information 

collection has not changed since the last 

OMB approval. 

Dated: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12448 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1768] 

Advisory Committee; Pharmacy 

Compounding Advisory Committee, 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pharmacy Compounding 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Pharmacy 

Compounding Advisory Committee for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until April 25, 2020. 

DATES: Authority for the Pharmacy 

Compounding Advisory Committee will 

expire on April 25, 2020, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Chee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, 

PCAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Pharmacy Compounding Advisory 

Committee (the Committee). The 

committee is a non-discretionary 

Federal advisory committee established 

to provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to compounding drugs for human 

use and, as required, any other product 

for which FDA has regulatory 

responsibility. 

The Committee shall provide advice 

on scientific, technical, and medical 

issues concerning drug compounding 

under sections 503A and 503B of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 353a and 353b), and, as 

required, any other product for which 

FDA has regulatory responsibility, and 

make appropriate recommendations to 

the Commissioner. 

The Committee shall consist of a core 

of 12 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 


daltland on DSKBBV9HB2PROD with NOTICES
27010 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 

pharmaceutical compounding, 

pharmaceutical manufacturing, 

pharmacy, medicine, and related 

specialties. These members will include 

representatives from the National 

Association of Boards of Pharmacy, the 

United States Pharmacopeia, 

pharmacists with current experience 

and expertise in compounding, 

physicians with background and 

knowledge in compounding, and patient 

and public health advocacy 

organizations. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all non-Federal 

members of this Committee serve as 

Special Government Employees. The 

core of voting members may include one 

or more technically qualified members, 

selected by the Commissioner or 

designee, who are identified with 

consumer interests and are 

recommended by either a consortium of 

consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one or more non-voting 

members who are identified with 

industry interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Drugs/ 

PharmacyCompounding

AdvisoryCommittee/ucm381305.htm or 

by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12440 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1725] 

Advisory Committee; Peripheral and 

Central Nervous System Drugs 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Peripheral and Central 

Nervous System Drugs Advisory 

Committee by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

Peripheral and Central Nervous System 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until June 4, 2020. 

DATES: Authority for the Peripheral and 

Central Nervous System Drugs Advisory 

Committee will expire on June 4, 2020, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Yinghua Wang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002; 301– 

796–9001, email: PCNS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Peripheral and Central Nervous System 

Drugs Advisory Committee. The 

committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Peripheral and Central Nervous 

System Drugs Advisory Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of neurologic 

diseases. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

neurology, neuropharmacology, 

neuropathology, otolaryngology, 

epidemiology or statistics, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Almost all non-Federal members 

of this committee serve as Special 

Government Employees. The core of 

voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting member who is 

identified with industry interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Drugs/ 

PeripheralandCentralNervousSystem

DrugsAdvisoryCommittee/default.htm 

or by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12443 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–0327] 

Determination That MUTAMYCIN 

(Mitomycin) Injectable, 5 Milligrams/ 

Vial and 20 Milligrams/Vial, 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 MUTAMYCIN 

(mitomycin) injectable, 5 milligrams 

(mg)/vial and 20 mg/vial, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for MUTAMYCIN 

(mitomycin) injectable, 5 mg/vial and 20 

mg/vial, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 


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