Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 1977 

Place: Teleconference, Centers for 

Disease Control and Prevention, Room 

1080, 8 Corporate Square Boulevard, 

Atlanta, Georgia 30329–4027. 

Agenda: To review and evaluate grant 

applications. 

FOR FURTHER INFORMATION CONTACT: 

Gregory Anderson, M.S., M.P.H., 

Scientific Review Officer, CDC, 1600 

Clifton Road, NE, Mailstop US8–1, 

Atlanta, Georgia 30329–4027, (404) 718– 

8833, ganderson@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–00282 Filed 1–8–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0001] 

Proposed Revised Vaccine Information 

Materials 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: Under the National 

Childhood Vaccine Injury Act (NCVIA), 

the Centers for Disease Control and 

Prevention (CDC) within the 

Department of Health and Human 

Services (HHS) develops vaccine 

information materials that all health 

care providers are required to give to 

patients/parents prior to administration 

of specific vaccines. HHS/CDC seeks 

written comment on proposed updated 

vaccine information statements for 

vaccines covered by the National 

Vaccine Injury Compensation Program 

(VICP). 

DATES: Written comments must be 

received on or before March 12, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0001, by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Written comments should be 

addressed to Suzanne Johnson-DeLeon 

(VISComments@cdc.gov), National 

Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention, 

Mailstop H24–6, 1600 Clifton Road NE, 

Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

docket number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne Johnson-DeLeon, National 

Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention, 

Mailstop H24–6, 1600 Clifton Road NE, 

Atlanta, Georgia 30329; VISComments@

cdc.gov. 

SUPPLEMENTARY INFORMATION: The 

National Childhood Vaccine Injury Act 

of 1986 (Pub. L. 99–660), as amended by 

section 708 of Public Law 103–183, 

added section 2126 to the Public Health 

Service Act. Section 2126, codified at 42 

U.S.C. 300aa–26, requires the Secretary 

of Health and Human Services to 

develop and disseminate vaccine 

information materials for distribution by 

all health care providers in the United 

States to any patient (or to the patient’s 

parent or legal representative in the case 

the patient is a child) receiving vaccines 

covered under the National Vaccine 

Injury Compensation Program (VICP). 

Development and revision of the 

vaccine information materials, also 

known as vaccine information 

statements (VISs), have been delegated 

by the Secretary to the Centers for 

Disease Control and Prevention (CDC). 

Section 2126 requires that the materials 

be developed, or revised, after notice to 

the public, with a 60-day comment 

period, and in consultation with the 

Advisory Commission on Childhood 

Vaccines, appropriate health care 

provider and parent organizations, and 

the Food and Drug Administration. The 

law also requires that the information 

contained in the materials be based on 

available data and information, be 

presented in understandable terms, and 

include: 

(1) A concise description of the 

benefits of the vaccine, 

(2) A concise description of the risks 

associated with the vaccine, 

(3) A statement of the availability of 

the National Vaccine Injury 

Compensation Program, and 

(4) Such other relevant information as 

may be determined by the Secretary. 

The vaccines initially covered under 

the National Vaccine Injury 

Compensation Program were diphtheria, 

tetanus, pertussis, measles, mumps, 

rubella and poliomyelitis vaccines. 

Since April 15, 1992, any health care 

provider in the United States who 

intends to administer one of these 

covered vaccines is required to provide 

copies of the relevant vaccine 

information materials prior to 

administration of any of these vaccines. 

Since then, the following vaccines have 

been added to the National Vaccine 

Injury Compensation Program, requiring 

provision of vaccine information 

materials before vaccine administration 

for them as well: Hepatitis B, 

Haemophilus influenzae type b (Hib), 

varicella (chickenpox), pneumococcal 

conjugate, rotavirus, hepatitis A, 

meningococcal, human papillomavirus 

(HPV), and seasonal influenza vaccines. 

Instructions for use of the vaccine 

information materials are found on the 

CDC website at: https://www.cdc.gov/ 

vaccines/hcp/vis/index.html. 

CDC is proposing updated versions to 

simplify, streamline, and standardize 

the content and formatting of the 

vaccine information statements. 

As proposed, each of the updated 

VISs contains the same seven sections. 

Formatting of the documents is 

identical, using the same fonts and 

layout. 

Section 1 (‘‘Why get vaccinated?’’) 

provides an overview of the disease(s) 

prevented by the vaccine. This section 

is being updated to provide a clearer, 

more plain-language description of the 

disease and its impact. 

Section 2 (e.g., ‘‘Hepatitis A vaccine’’) 

describes the vaccine and 

recommendations for its use. A general 

description of the usually-recommended 

schedule is provided and groups of 

people for whom the vaccine is 

typically recommended are identified. 

Updates to the text in this section 

remove some of the more specific 

details related to schedules and 

numbers of doses, which can vary 

depending on an individual patient’s 

circumstances. 

Section 3 (‘‘Talk with your health care 

provider’’) highlights conditions and 

medical history that should be brought 

to the vaccine provider’s attention when 

deciding whether the vaccine is 

appropriate for an individual patient. 

Previously entitled ‘‘Some people 

should not get this vaccine,’’ this 

section has been refocused to be broader 


jbell on DSKJLSW7X2PROD with NOTICES
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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