83968 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 

Methodological Research for the 

Medicare Current Beneficiary Survey 

(MCBS); Use: The current generic 

clearance for MCBS Questionnaire 

Testing and Methodological Research 

encompasses development and testing 

of MCBS questionnaires, 

instrumentation, and data collection 

protocols, as well as a mechanism for 

conducting methodological 

experiments. The current clearance 

includes conducting field tests and 

experiments, including split ballot 

experiments, within the MCBS 

production environment, and 

conducting usability tests. The purpose 

of this OMB clearance package is to 

revise the current clearance to expand 

the methods to allow for field tests 

outside of MCBS production Field tests 

conducted within production do not 

incur any additional burden on 

respondents whereas tests conducted 

outside production must account for 

additional respondent burden. The 

MCBS is a continuous, multipurpose 

survey of a nationally representative 

sample of aged, disabled, and 

institutionalized Medicare beneficiaries. 

The MCBS, which is sponsored by the 

Centers for Medicare & Medicaid 

Services (CMS), is the only 

comprehensive source of information on 

the health status, health care use and 

expenditures, health insurance 

coverage, and socioeconomic and 

demographic characteristics of the 

entire spectrum of Medicare 

beneficiaries. The core of the MCBS is 

a series of interviews with a stratified 

random sample of the Medicare 

population, including aged and disabled 

enrollees, residing in the community or 

in institutions. Questions are asked 

about enrollees’ patterns of health care 

use, charges, insurance coverage, and 

payments over time. Respondents are 

asked about their sources of health care 

coverage and payment, their 

demographic characteristics, their 

health and work history, and their 

family living circumstances. In addition 

to collecting information through the 

core questionnaire, the MCBS collects 

information on special topics. Form 

Number: CMS–10549 (OMB control 

number: 0938–1275); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 11,655; Total Annual 

Responses: 11,655; Total Annual Hours: 

3,947. (For policy questions regarding 

this collection, contact William Long at 

410–786–7927.) 

Dated: December 17, 2020. 

William N. Parham III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–28224 Filed 12–22–20; 8:45 am] 

BILLING CODE 4120–01–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 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 veterinary feed 

directive regulation. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 22, 2021. 

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 February 22, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 22, 2021. 

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– 

2010–N–0155 for ‘‘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 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• 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 


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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83969 

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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), 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 

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 (b)(8) 

and (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 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 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 

products from treated animals will be 

free of unsafe drug residues. 

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 Application) 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.

188 1 188 0.125 (7 minutes) ............................. 24 

558.6(c)(6) requires a distributor to 

notify FDA within 30 days of any 

change in ownership, business 

name, or business address.

192 1 192 0.125 (7 minutes) ............................. 24 

Total .................................................. ........................ ........................ ........................ ........................................................... 48 

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


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83970 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 

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 (consignor) first 

obtains a written acknowledgment letter 

from the receiving distributor 

(consignee) before the feed is shipped. 

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

558.6(a)(4), (c)(3), (4), and (8); required recordkeeping by distributors.9,635 545.1 5,252,038 0.0167 (1 minute) ............................. 87,709 

Total .................................................. ........................ ........................ ........................ ........................................................... 112,759 

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 

acknowledgment letter from the 

receiving distributor (consignee) before 

the feed is shipped (§ 558.6(c)(8)). 

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 0.125 (7 minutes) ............................ 93,750 

558.6(c)(8); required disclosure (acknowledgment 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)). 


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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83971 

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.). 

Based on a review of the information 

collection since our last request for 

OMB approval, there has been a 

significant increase in the number of 

VFD distributors due to changes to the 

VFD regulations that were implemented 

in 2017. Since implementation, the 

number of approved VFD drugs has 

increased. 

Dated: December 17, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28353 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0386] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Orphan Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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: Submit written comments 

(including recommendations) on the 

collection of information by January 22, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0167. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Orphan Drugs 

OMB Control Number 0910–0167— 

Revision 

This information collection supports 

FDA regulations implementing sections 

525, 526, 527, and 528 of the Federal 

Food, Drug and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360aa, 360bb, 360cc, and 

360dd), as well as related guidance. 

Sections 525, 526, 527, and 528 of the 

FD&C Act pertain to the development of 

drugs for rare diseases or conditions, 

including biological products and 

antibiotics, otherwise known or referred 

to as ‘‘Orphan Drugs.’’ Specifically, 

section 525 of the FD&C Act requires 

written recommendations on studies 

required for approval of a marketing 

application for a drug for a rare disease 

or condition. The information collection 

in 21 CFR 316.10, 316.12, and 316.14 is 

approved under OMB control numbers 

0910–0001 and 0910–0014. Section 526 

of the FD&C Act provides for 

designation of drugs as orphan drugs 

when certain conditions are met, section 

527 provides conditions under which a 

sponsor of an approved orphan drug 

enjoys exclusive FDA marketing 

approval for that drug for the orphan 

indication for a period of 7 years, and, 

finally, section 528 is intended to 

encourage sponsors to make 

investigational orphan drugs available 

for treatment of persons in need on an 

open protocol basis before the drug has 

been approved for general marketing. 

Open protocols may permit patients 

who are not part of the formal clinical 

investigation to obtain treatment where 

adequate supplies exist and no 

alternative effective therapy is available. 

We have issued regulations in part 

316 (21 CFR part 316) to implement the 

Orphan Drug provisions of the FD&C 

Act and to set forth procedures and 

requirements related to requesting 

recommendations for investigations of 

drugs for rare diseases or conditions, 

requesting designation of a drug for a 

rare disease or condition, or requesting 

exclusive approval for a drug for a rare 

disease or condition. To assist 

respondents and to be consistent with 

§ 316.50, our Office of Orphan Products 

Development (OOPD) maintains and 

makes publicly available guidance 

documents that apply to the Orphan 

Drug provisions of the FD&C Act and 

regulations in part 316. The list is 

maintained on the internet and 

guidance documents are issued in 

accordance with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

Accordingly, we are revising the 

information collection to include 

Agency guidance. The document 

entitled ‘‘Meetings with the Office of 

Orphan Products Development: 

Guidance for Industry, Researchers, 

Patient Groups, and Food and Drug 

Administration Staff’’ provides 

recommendations to industry, 

researchers, patient groups, and other 

stakeholders interested in requesting a 

meeting, including a teleconference, 

with OOPD on issues related to orphan 

drug designation requests, humanitarian 

use device designation requests, rare 

pediatric disease designation requests, 

funding opportunities through the 

Orphan Products Grants Program and 

the Pediatric Device Consortia Grants 

Program, and orphan product patientrelated topics of concern. It is also 

intended to assist OOPD staff in 

addressing such meeting requests. This 

guidance describes procedures for 

requesting, preparing, scheduling, 

conducting, and documenting such 

meetings and discusses background 

information we recommend be included 

in such requests. Information collection 

attendant to recommendations in the 

guidance are currently approved under 

OMB control number 0910–0787; 

however, for efficiency of Agency 

operations, we are consolidating it into 

this related information collection. The 

guidance is available at https://

www.fda.gov/media/92815/download. 

The FDA Orphan Drug Designation 

Request Form (Form FDA 4035) is 

intended to benefit sponsors who desire 

to seek orphan designation of drugs 

intended for rare diseases or conditions 

from only FDA. The form is a simplified 


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