1978 Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 

in scope. Some of the conditions listed 

in this section are contraindications or 

precautions to vaccination, while others 

are intended to prompt the patient and 

provider to ask additional questions and 

investigate further. 

Section 4 (‘‘Risks of a vaccine 

reaction’’) sets forth adverse events that 

could occur after vaccination. Included 

are discussion of the risk of severe 

allergic reaction and the remote 

possibility of serious injury or death. 

Language for this section has been 

standardized across VISs to the extent 

possible while still adhering to vaccinespecific information from the 

recommendations of the Advisory 

Committee on Immunization Practices 

(ACIP). 

The complete text of section 5 (‘‘What 

if there I a serious problem?’’), section 

6 (‘‘The National Vaccine Injury 

Compensation Program’’), and section 7 

(‘‘How can I learn more?’’), as proposed, 

matches exactly across all of the vaccine 

information materials, except for the 

VIS for rotavirus vaccine which 

includes additional information related 

to the risk of intussusception (a very 

serious adverse event that is specific to 

rotavirus vaccine) in sections 5 and 6. 

Text in all sections of the VISs is 

updated using plain language terms and 

concepts, and removing some of the 

more detailed numerical and statistical 

data, to make the documents more 

easily understandable to the general 

public. Because the vaccine information 

statements are intended for patient 

education, content that is relevant for 

providers but not for patients is 

removed. Language has been updated to 

reflect a provider-neutral approach, 

reflecting the fact that vaccines may be 

administered by medical professionals 

in a variety of specialty fields (e.g., 

using the term ‘‘health care provider’’ 

instead of ‘‘doctor’’ or ‘‘nurse’’). 

The vaccine information materials 

referenced in this notice are being 

developed in consultation with the 

Advisory Commission on Childhood 

Vaccines, the Food and Drug 

Administration, and parent and health 

care provider groups. 

We invite written comment on the 

proposed vaccine information materials. 

Copies of the proposed vaccine 

information materials are available at 

http://www.regulations.gov (see Docket 

Number CDC–2021–0001). Comments 

submitted will be considered in 

finalizing these materials. When the 

final materials are published in the 

Federal Register, the notice will include 

an effective date for their mandatory 

use. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–00266 Filed 1–8–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No. 0970–0356] 

Submission for OMB Review; 

Formative Data Collections for ACF 

Research and Evaluation 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) proposes 

to extend data collection under the 

existing overarching generic clearance 

for Formative Data Collections for ACF 

Research and Evaluation (OMB #0970– 

0356). There are no changes to the 

proposed types of information 

collection or uses of data, but the 

request does include an increase to the 

estimated number of respondents and, 

therefore, the overall burden estimate. 

DATES: Comments due within 30 days of 

publication. 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. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: ACF programs promote the 

economic and social well-being of 

families, children, individuals, and 

communities. OPRE studies ACF 

programs, and the populations they 

serve, through rigorous research and 

evaluation projects. These include 

evaluations of existing programs, 

evaluations of innovative approaches to 

helping low-income children and 

families, research syntheses, and 

descriptive and exploratory studies. 

OPRE’s research serves to provide 

further understanding of current 

programs and service populations, 

explore options for program 

improvement, and assess alternative 

policy and program designs. OPRE 

anticipates undertaking a variety of new 

research projects related to welfare, 

employment and self-sufficiency, Head 

Start, child care, healthy marriage and 

responsible fatherhood, family and 

youth services, home visiting, child 

welfare, and other areas of interest to 

ACF. Under this generic clearance, ACF 

engages in a variety of formative data 

collections with researchers, 

practitioners, technical assistance 

providers, service providers, and 

potential participants throughout the 

field to fulfill the following goals: (1) 

Inform the development of ACF 

research, (2) maintain a research agenda 

that is rigorous and relevant, (3) ensure 

that research products are as current as 

possible, and (4) inform the provision of 

technical assistance. ACF uses a variety 

of techniques including semi-structured 

discussions, focus groups, surveys, and 

telephone or in-person interviews, in 

order to reach these goals. 

Following standard OMB 

requirements, OPRE will submit a 

change request for each individual data 

collection activity under this generic 

clearance. Each request will include the 

individual instrument(s), a justification 

specific to the individual information 

collection, and any supplementary 

documents. OMB should review 

requests within 10 days of submission. 

Respondents: Example respondents 

include: key stakeholder groups 

involved in ACF projects and programs, 

state or local government officials, 

service providers, participants in ACF 

programs or similar comparison groups, 

experts in fields pertaining to ACF 

research and programs, or others 

involved in conducting ACF research or 

evaluation projects. 


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Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 1979 

ANNUAL BURDEN ESTIMATES

Instrument 

Estimated total 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Semi-Structured Discussions and Focus Groups ............................................ 3,000 1 2 6,000 

Interviews ......................................................................................................... 1,500 1 1 1,500 

Questionnaires/Surveys ................................................................................... 1,125 1 .5 563 

Estimated Total Annual Burden 

Hours: 8,063 

Authority: Social Security Act, Sec. 1110 

[42 U.S.C. 1310]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–00209 Filed 1–8–21; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2635] 

Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs 

Intended for Use In or On Feed: A 

Concept Paper; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

requesting comments on a document 

entitled ‘‘Potential Approach for 

Defining Durations of Use for Medically 

Important Antimicrobial Drugs Intended 

for Use In or On Feed: A Concept 

Paper.’’ The concept paper outlines a 

potential framework for how sponsors of 

new animal drug products containing 

medically important antimicrobial drugs 

approved for use in or on animal feed 

might voluntarily establish 

appropriately defined durations of 

therapeutic administration to foodproducing animals where none 

currently exist. Establishing 

appropriately defined durations of use 

to mitigate development of 

antimicrobial resistance would be 

consistent with previous efforts by FDA 

to protect public health by promoting 

the judicious use of these drugs in foodproducing animals. 

DATES: Submit either electronic or 

written comments by April 12, 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 April 12, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 12, 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– 

2016–D–2635 for ‘‘Potential Approach 

for Defining Durations of Use for 

Medically Important Antimicrobial 

Drugs Intended for Use In or On Feed: 

A Concept Paper.’’ 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 

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 


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