Proposed Data Collections Submitted for Public Comment and Recommendations, 62138-62139 [2016-21609]

Download as PDF 62138 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices Following consultation and review of comments submitted, the vaccine information materials covering polio vaccine have been finalized and are available to download from http:// www.cdc.gov/vaccines/hcp/vis/ index.html or http:// www.regulations.gov (see Docket Number CDC–2015–0029). The Vaccine Information Statement (VIS) is ‘‘Polio Vaccine: What You Need to Know,’’ publication date July 20, 2016. With publication of this notice, by November 1, 2016, all health care providers must discontinue use of the previous edition and provide copies of these updated polio vaccine information materials prior to immunization in conformance with CDC’s August 9, 2016 Instructions for the Use of Vaccine Information Statements. Dated: September 1, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016–21575 Filed 9–7–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–16–0955; Docket No. CDC–2016– 0089] Proposed Data Collections Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention Pediatric Audiology Links to Services (EDHI–PALS) DATES: Written comments must be received on or before November 7, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC–2016– 0089 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instruction for submitting comments. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 • Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– D74, 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 Regulation.gov, including any personal information provided. For access to the docket to read the background documents or comments received, go to Regulations.gov. FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30329. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, and each reinstatement of previously approved information collection before submitting the collect to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Early Hearing Detection and Intervention—Pediatric Audiology Links to Service (EHDI–PALS) Survey (OMB No. 0920–0955, Expiration 03/31/ 2017)—Extension—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Human Development and Disability, located within NCBDDD, promotes the health of babies, children, and adults, with a focus on preventing birth defects and developmental disabilities and optimizing the health outcomes of those with disabilities. Since the passage of the Early Hearing Detection and Intervention (EHDI) Act, 98% of newborn infants are now screened for hearing loss prior to hospital discharge. However, many of these infants have not received needed hearing tests and follow up services after their hospital discharges. The 2013 national average loss to follow-up/loss to documentation rate is at 32%. This rate remains an area of critical concern for state EHDI programs and CDC–EHDI team’s goal of timely diagnosis by 3 months of age and intervention by 6 months of age. Many states cite the lack of audiology resources as the main factor behind the high loss to follow-up. To compound the problem, many pediatric audiologists may be proficient evaluating children age 5 and older but are not proficient with diagnosing infants or younger children because children age 5 and younger require a different skill set. There is still no existing literature or database available to help states verify and quantify their states’ true follow up capacity until this project went live in 2013. Meeting since April 2010, the EHDI– PALS workgroup has sought consensus on the loss to follow-up/loss to documentation issue facing the EHDI programs. A survey based on standard of care practice was developed for state EHDI programs to quantify the pediatric audiology resource distribution within their state, particularly audiology facilities that are equipped to provide follow up services for children age five and younger. After three years of data collection, data suggested that children residing in certain regions of the US who were loss to follow up were due to the distance parents had to travel to E:\FR\FM\08SEN1.SGM 08SEN1 62139 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices reach a pediatric audiology facility. For example, parents who reside in western region of Nebraska and Iowa on average have to drive over 100 miles and in Montana over 200 miles to reach a pediatric audiology facility. CDC is requesting an Office of Management and Budget (OMB) approval to continue collecting audiology facility information from audiologists or facility managers so both parents, physicians and state EHDI programs will have a tool to find where the pediatric audiology facilities are located. This survey will continue to allow the CDC–EHDI team and state EHDI programs to compile a systematic, quantifiable distribution of audiology facilities and the capacity of each facility to provide services for children age five and younger. The data collected will also allow the CDC–EHDI team to analyze facility distribution data to improve technical assistance to state EHDI programs. answers. Both the American SpeechLanguage-Hearing Association and the American Academy of Audiology are members of the EHDI–PALS workgroup and will continue to disseminate a request through association enewsletters and e-announcements to all audiologists who provide services to children younger than five years of age to complete the EHDI–PALS survey. It is estimated that potentially an additional 400 new audiologists will read through the purpose statement located on page one of the survey to decide whether or not to complete the survey. This will take one minute per person. It is estimated that 200 audiologists will complete the survey which will average nine minutes per respondent. The nine minutes calculation is based on a previous timed pre-test with six volunteer audiologists. There are no costs to respondents other than their time. The total burden hours are 64. There will be no revision done to the survey because the data collected in the past three years has proven to be valuable and appropriate as evidenced by the high usage rate. Consumers have accessed the facility information over 140,000 times as of April 2016. To minimize burden and improve convenience, the survey will continue to be available via a secure password protected Web site. Placing the survey on the internet ensures convenient, ondemand access by the audiologists. Financial cost is minimized because no mailing fee will be associated with sending or responding to this survey. EHDI–PALS currently has 1,005 facilities in the database since the beginning of the data collection. All 1,005 facilities’ contact will receive a brief email from the University of Maine to remind them to review their survey answers. It is estimated that approximately 800 audiologists will do so. It takes approximately two minutes per person to review the survey Number of responses per respondent Number of respondents Form name Average burden per response (in hours) Total burden (in hours) Annual Survey Review .................................................................................... Survey Introduction .......................................................................................... Survey .............................................................................................................. 800 400 200 1 1 1 2/60 1/60 9/60 27 7 30 Total .......................................................................................................... 1,400 ........................ ........................ 64 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016–21609 Filed 9–7–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2016–0015] Final Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. mstockstill on DSK3G9T082PROD with NOTICES AGENCY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa–26), CDC must develop vaccine information materials that all health care providers are required to SUMMARY: VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 give to patients/parents prior to administration of specific vaccines. On February 8, 2016, CDC published a notice in the Federal Register (81 FR 6520) seeking public comments on proposed updated vaccine information materials for hepatitis A and hepatitis B vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for hepatitis A and hepatitis B vaccines. Copies of the final vaccine information materials for hepatitis A and hepatitis B vaccines are available to download from http:// www.cdc.gov/vaccines/hcp/vis/ index.html or http:// www.regulations.gov (see Docket Number CDC–2016–0015). Beginning no later than November 1, 2016, each health care provider who administers hepatitis A or hepatitis B vaccine to any child or adult in the United States shall provide copies of the relevant vaccine information materials referenced in this notice, in conformance with the August 9, 2016 CDC Instructions for the Use of Vaccine Information Statements prior to providing such vaccinations. DATES: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Suzanne Johnson-DeLeon (msj1@ cdc.gov), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A–19, 1600 Clifton Road NE., Atlanta, Georgia 30329. 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 parent or legal representative in the case of 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 (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). Section 2126 requires that the materials SUPPLEMENTARY INFORMATION: E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62138-62139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21609]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0955; Docket No. CDC-2016-0089]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as requires by the Paperwork 
Reduction Act of 1995. This notice invites comments on Early Hearing 
Detection and Intervention Pediatric Audiology Links to Services (EDHI-
PALS)

DATES: Written comments must be received on or before November 7, 2016.

ADDRESSES:  You may submit comments, identified by Docket No. CDC-2016-
0089 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instruction for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, 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 Regulation.gov, including any personal information 
provided. For access to the docket to read the background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, and each 
reinstatement of previously approved information collection before 
submitting the collect to OMB for approval. To comply with this 
requirement, we are publishing this notice of a proposed data 
collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Early Hearing Detection and Intervention--Pediatric Audiology Links 
to Service (EHDI-PALS) Survey (OMB No. 0920-0955, Expiration 03/31/
2017)--Extension--National Center on Birth Defects and Developmental 
Disabilities (NCBDDD), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The Division of Human Development and Disability, located within 
NCBDDD, promotes the health of babies, children, and adults, with a 
focus on preventing birth defects and developmental disabilities and 
optimizing the health outcomes of those with disabilities. Since the 
passage of the Early Hearing Detection and Intervention (EHDI) Act, 98% 
of newborn infants are now screened for hearing loss prior to hospital 
discharge. However, many of these infants have not received needed 
hearing tests and follow up services after their hospital discharges. 
The 2013 national average loss to follow-up/loss to documentation rate 
is at 32%. This rate remains an area of critical concern for state EHDI 
programs and CDC-EHDI team's goal of timely diagnosis by 3 months of 
age and intervention by 6 months of age. Many states cite the lack of 
audiology resources as the main factor behind the high loss to follow-
up. To compound the problem, many pediatric audiologists may be 
proficient evaluating children age 5 and older but are not proficient 
with diagnosing infants or younger children because children age 5 and 
younger require a different skill set. There is still no existing 
literature or database available to help states verify and quantify 
their states' true follow up capacity until this project went live in 
2013.
    Meeting since April 2010, the EHDI-PALS workgroup has sought 
consensus on the loss to follow-up/loss to documentation issue facing 
the EHDI programs. A survey based on standard of care practice was 
developed for state EHDI programs to quantify the pediatric audiology 
resource distribution within their state, particularly audiology 
facilities that are equipped to provide follow up services for children 
age five and younger. After three years of data collection, data 
suggested that children residing in certain regions of the US who were 
loss to follow up were due to the distance parents had to travel to

[[Page 62139]]

reach a pediatric audiology facility. For example, parents who reside 
in western region of Nebraska and Iowa on average have to drive over 
100 miles and in Montana over 200 miles to reach a pediatric audiology 
facility.
    CDC is requesting an Office of Management and Budget (OMB) approval 
to continue collecting audiology facility information from audiologists 
or facility managers so both parents, physicians and state EHDI 
programs will have a tool to find where the pediatric audiology 
facilities are located. This survey will continue to allow the CDC-EHDI 
team and state EHDI programs to compile a systematic, quantifiable 
distribution of audiology facilities and the capacity of each facility 
to provide services for children age five and younger. The data 
collected will also allow the CDC-EHDI team to analyze facility 
distribution data to improve technical assistance to state EHDI 
programs.
    There will be no revision done to the survey because the data 
collected in the past three years has proven to be valuable and 
appropriate as evidenced by the high usage rate. Consumers have 
accessed the facility information over 140,000 times as of April 2016. 
To minimize burden and improve convenience, the survey will continue to 
be available via a secure password protected Web site. Placing the 
survey on the internet ensures convenient, on-demand access by the 
audiologists. Financial cost is minimized because no mailing fee will 
be associated with sending or responding to this survey.
    EHDI-PALS currently has 1,005 facilities in the database since the 
beginning of the data collection. All 1,005 facilities' contact will 
receive a brief email from the University of Maine to remind them to 
review their survey answers. It is estimated that approximately 800 
audiologists will do so. It takes approximately two minutes per person 
to review the survey answers. Both the American Speech-Language-Hearing 
Association and the American Academy of Audiology are members of the 
EHDI-PALS workgroup and will continue to disseminate a request through 
association e-newsletters and e-announcements to all audiologists who 
provide services to children younger than five years of age to complete 
the EHDI-PALS survey. It is estimated that potentially an additional 
400 new audiologists will read through the purpose statement located on 
page one of the survey to decide whether or not to complete the survey. 
This will take one minute per person. It is estimated that 200 
audiologists will complete the survey which will average nine minutes 
per respondent. The nine minutes calculation is based on a previous 
timed pre-test with six volunteer audiologists. There are no costs to 
respondents other than their time.
    The total burden hours are 64.

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Annual Survey Review............................             800               1            2/60              27
Survey Introduction.............................             400               1            1/60               7
Survey..........................................             200               1            9/60              30
                                                 ---------------------------------------------------------------
    Total.......................................           1,400  ..............  ..............              64
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-21609 Filed 9-7-16; 8:45 am]
BILLING CODE 4163-18-P