Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 27007 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Child Welfare Information Gateway’s Targeted Survey .................................. 2,660 1 0.084 223.44 

Child Welfare Information Gateway’s Event Survey ....................................... 900 1 0.05 45 

Child Welfare Information Gateway’s Focus Group Guide ............................. 50 1 1 50 

Child Welfare Information Gateway’s General Customer Survey: Questions 

for Professionals .......................................................................................... 960 1 0.084 80.64 

Child Welfare Information Gateway’s General Customer Survey: Questions 

for Students .................................................................................................. 480 1 0.05 24 

Child Welfare Information Gateway’s General Customer Survey: Questions 

for Personal Customers ............................................................................... 960 1 0.05 48 

Market Research Sub-Study: Online Information Habits and Preferences 

Survey (for child welfare professionals in state, county, and private agencies) .............................................................................................................. 1,800 1 0.5 900 

Market Research Sub-Study: Online Information Habits and Preferences 

Survey (for child welfare professionals working with tribes) ........................ 800 1 0.5 400 

Market Research Sub-Study: Online Information Habits and Preferences 

Survey (for legal professionals working in child welfare) ............................ 1,400 1 0.5 700 

Market Research Sub-Study: Online Information Habits and Preferences 

Survey (for students planning to enter the child welfare workforce) ........... 810 1 0.5 405 

Market Research Sub-Study: Focus Groups on Information Habits and Preferences ......................................................................................................... 100 1 1.5 150 

Estimated Total Annual Burden 

Hours: 3,026.08 hours. 

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, 330 C Street SW, 

Washington, DC 20201. Attention 

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 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–12468 Filed 6–8–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0155] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing 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. 

DATES: Fax written comments on the 

collection of information by July 11, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0363. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Veterinary Food Directive 

OMB Control Number 0910–0363— 

Extension 

Section 504 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 354) 

establishes a regulatory category for 

certain new animal drugs called 

veterinary feed directive (VFD) drugs. 

The 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 

(§ 558.6(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 FDA 


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27008 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 

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 cost 

effectively 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 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 

products from treated animals will be 

free of unsafe drug residues. 

We are retaining the estimates used in 

FDA’s analysis of the information 

collection provisions in the final rule 

entitled ‘‘Veterinary Feed Directive,’’ 

published in the Federal Register of 

June 3, 2015 (80 FR 31708 at 31728), 

and approved by OMB. 

A. Reporting Requirements 

Description of Respondents: VFD 

Feed Distributors and VFD Drug 

Sponsors. 

A distributor of animal feed 

containing a VFD drug must notify FDA 

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 FDA 

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). 

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 FDA prior 

to the first time it distributes a VFD feed.

300 1 300 0.125 (7 minutes) ...... 37.5 

558.6(c)(6) requires a distributor to notify FDA 

within 30 days of any change in ownership, business name, or business address.

20 1 20 0.125 (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 

(veterinarian, distributor, and 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 FDA 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 feeds 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 

responses 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 0.0167 (1 minute) ...... 25,050 

558.6(a)(4), (c)(3), (c)(4), and (c)(8); required recordkeeping by distributors.1,376 545.1 750,000 0.0167 (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. 

FDA 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. 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 


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