81_FR_62312 81 FR 62138 - Proposed Data Collections Submitted for Public Comment and Recommendations

81 FR 62138 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 174 (September 8, 2016)

Page Range62138-62139
FR Document2016-21609

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)

Federal Register, Volume 81 Issue 174 (Thursday, September 8, 2016) 
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62138-62139]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21609]


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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
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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

62138 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices Following consultation and review of • Mail: Leroy A. Richardson, personnel and to be able to respond to comments submitted, the vaccine Information Collection Review Office, a collection of information, to search information materials covering polio Centers for Disease Control and data sources, to complete and review vaccine have been finalized and are Prevention, 1600 Clifton Road NE., MS– the collection of information; and to available to download from http:// D74, Atlanta, Georgia 30329. transmit or otherwise disclose the www.cdc.gov/vaccines/hcp/vis/ Instructions: All submissions received information. index.html or http:// must include the agency name and Proposed Project www.regulations.gov (see Docket Docket Number. All relevant comments Number CDC–2015–0029). The Vaccine received will be posted without change Early Hearing Detection and Information Statement (VIS) is ‘‘Polio to Regulation.gov, including any Intervention—Pediatric Audiology Vaccine: What You Need to Know,’’ personal information provided. For Links to Service (EHDI–PALS) Survey publication date July 20, 2016. access to the docket to read the (OMB No. 0920–0955, Expiration 03/31/ With publication of this notice, by background documents or comments 2017)—Extension—National Center on November 1, 2016, all health care received, go to Regulations.gov. Birth Defects and Developmental providers must discontinue use of the FOR FURTHER INFORMATION CONTACT: Disabilities (NCBDDD), Centers for previous edition and provide copies of Leroy A. Richardson, Information Disease Control and Prevention (CDC). these updated polio vaccine information Collection Review Office, Centers for Background and Brief Description materials prior to immunization in Disease Control and Prevention, 1600 The Division of Human Development conformance with CDC’s August 9, 2016 Clifton Road NE., MS–D74, Atlanta, and Disability, located within NCBDDD, Instructions for the Use of Vaccine Georgia 30329. promotes the health of babies, children, Information Statements. SUPPLEMENTARY INFORMATION: Under the and adults, with a focus on preventing Dated: September 1, 2016. Paperwork Reduction Act of 1995 (PRA) birth defects and developmental Sandra Cashman, (44 U.S.C. 3501–3520), Federal agencies disabilities and optimizing the health Executive Secretary, Centers for Disease must obtain approval from the Office of outcomes of those with disabilities. Control and Prevention. Management and Budget (OMB) for each Since the passage of the Early Hearing [FR Doc. 2016–21575 Filed 9–7–16; 8:45 am] collection of information they conduct Detection and Intervention (EHDI) Act, BILLING CODE 4163–18–P or sponsor. In addition, the PRA also 98% of newborn infants are now requires Federal agencies to provide a screened for hearing loss prior to 60-day notice in the Federal Register hospital discharge. However, many of DEPARTMENT OF HEALTH AND concerning each proposed collection of these infants have not received needed HUMAN SERVICES information, and each reinstatement of hearing tests and follow up services previously approved information after their hospital discharges. The 2013 Centers for Disease Control and collection before submitting the collect national average loss to follow-up/loss Prevention to OMB for approval. To comply with to documentation rate is at 32%. This [60Day–16–0955; Docket No. CDC–2016– this requirement, we are publishing this rate remains an area of critical concern 0089] notice of a proposed data collection as for state EHDI programs and CDC–EHDI described below. team’s goal of timely diagnosis by 3 Proposed Data Collections Submitted Comments are invited on: (a) Whether months of age and intervention by 6 for Public Comment and the proposed collection of information months of age. Many states cite the lack Recommendations is necessary for the proper performance of audiology resources as the main of the functions of the agency, including factor behind the high loss to follow-up. AGENCY: Centers for Disease Control and whether the information shall have To compound the problem, many Prevention (CDC), Department of Health practical utility; (b) the accuracy of the pediatric audiologists may be proficient and Human Services (HHS). agency’s estimate of the burden of the evaluating children age 5 and older but ACTION: Notice with comment period. proposed collection of information; (c) are not proficient with diagnosing ways to enhance the quality, utility, and infants or younger children because SUMMARY: The Centers for Disease clarity of the information to be children age 5 and younger require a Control and Prevention (CDC), as part of collected; and (d) ways to minimize the different skill set. There is still no its continuing efforts to reduce public burden of the collection of information existing literature or database available burden and maximize the utility of on respondents, including through the to help states verify and quantify their government information, invites the use of automated collection techniques states’ true follow up capacity until this general public and other Federal or other forms of information project went live in 2013. agencies to take this opportunity to technology; and (e) estimates of capital Meeting since April 2010, the EHDI– comment on proposed and/or or start-up costs and costs of operation, PALS workgroup has sought consensus continuing information collections, as maintenance, and purchase of services on the loss to follow-up/loss to requires by the Paperwork Reduction to provide information. Burden means documentation issue facing the EHDI Act of 1995. This notice invites the total time, effort, or financial programs. A survey based on standard comments on Early Hearing Detection resources expended by persons to of care practice was developed for state and Intervention Pediatric Audiology generate, maintain, retain, disclose or EHDI programs to quantify the pediatric Links to Services (EDHI–PALS) provide information to or for a Federal audiology resource distribution within DATES: Written comments must be agency. This includes the time needed their state, particularly audiology mstockstill on DSK3G9T082PROD with NOTICES received on or before November 7, 2016. to review instructions; to develop, facilities that are equipped to provide ADDRESSES: You may submit comments, acquire, install and utilize technology follow up services for children age five identified by Docket No. CDC–2016– and systems for the purpose of and younger. After three years of data 0089 by any of the following methods: collecting, validating and verifying collection, data suggested that children • Federal eRulemaking Portal: information, processing and residing in certain regions of the US Regulations.gov. Follow the instruction maintaining information, and disclosing who were loss to follow up were due to for submitting comments. and providing information; to train the distance parents had to travel to VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1

Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62139 reach a pediatric audiology facility. For There will be no revision done to the answers. Both the American Speech- example, parents who reside in western survey because the data collected in the Language-Hearing Association and the region of Nebraska and Iowa on average past three years has proven to be American Academy of Audiology are have to drive over 100 miles and in valuable and appropriate as evidenced members of the EHDI–PALS workgroup Montana over 200 miles to reach a by the high usage rate. Consumers have and will continue to disseminate a pediatric audiology facility. accessed the facility information over request through association e- 140,000 times as of April 2016. To newsletters and e-announcements to all CDC is requesting an Office of minimize burden and improve audiologists who provide services to Management and Budget (OMB) convenience, the survey will continue children younger than five years of age approval to continue collecting to be available via a secure password audiology facility information from to complete the EHDI–PALS survey. It is protected Web site. Placing the survey estimated that potentially an additional audiologists or facility managers so both on the internet ensures convenient, on- parents, physicians and state EHDI 400 new audiologists will read through demand access by the audiologists. the purpose statement located on page programs will have a tool to find where Financial cost is minimized because no the pediatric audiology facilities are one of the survey to decide whether or mailing fee will be associated with not to complete the survey. This will located. This survey will continue to sending or responding to this survey. allow the CDC–EHDI team and state take one minute per person. It is EHDI–PALS currently has 1,005 EHDI programs to compile a systematic, facilities in the database since the estimated that 200 audiologists will quantifiable distribution of audiology beginning of the data collection. All complete the survey which will average facilities and the capacity of each 1,005 facilities’ contact will receive a nine minutes per respondent. The nine facility to provide services for children brief email from the University of Maine minutes calculation is based on a age five and younger. The data collected to remind them to review their survey previous timed pre-test with six will also allow the CDC–EHDI team to answers. It is estimated that volunteer audiologists. There are no analyze facility distribution data to approximately 800 audiologists will do costs to respondents other than their improve technical assistance to state so. It takes approximately two minutes time. EHDI programs. per person to review the survey The total burden hours are 64. Average Number of Number of burden per Total burden Form name responses per respondents response (in hours) respondent (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, give to patients/parents prior to FOR FURTHER INFORMATION CONTACT: Chief, Information Collection Review Office, administration of specific vaccines. On Suzanne Johnson-DeLeon (msj1@ Office of Scientific Integrity, Office of the February 8, 2016, CDC published a cdc.gov), National Center for Associate Director for Science, Office of the notice in the Federal Register (81 FR Immunization and Respiratory Diseases, Director, Centers for Disease Control and 6520) seeking public comments on Centers for Disease Control and Prevention. Prevention, Mailstop A–19, 1600 Clifton proposed updated vaccine information [FR Doc. 2016–21609 Filed 9–7–16; 8:45 am] Road NE., Atlanta, Georgia 30329. materials for hepatitis A and hepatitis B BILLING CODE 4163–18–P vaccines. Following review of SUPPLEMENTARY INFORMATION: The comments submitted and consultation National Childhood Vaccine Injury Act as required under the law, CDC has of 1986 (Pub. L. 99–660), as amended by DEPARTMENT OF HEALTH AND finalized the materials for hepatitis A HUMAN SERVICES section 708 of Public Law 103–183, and hepatitis B vaccines. Copies of the added section 2126 to the Public Health Centers for Disease Control and final vaccine information materials for Service Act. Section 2126, codified at 42 Prevention hepatitis A and hepatitis B vaccines are U.S.C. 300aa–26, requires the Secretary available to download from http:// of Health and Human Services to [Docket No. CDC–2016–0015] www.cdc.gov/vaccines/hcp/vis/ develop and disseminate vaccine index.html or http:// information materials for distribution by Final Revised Vaccine Information www.regulations.gov (see Docket all health care providers in the United Materials for Hepatitis A and Hepatitis Number CDC–2016–0015). States to any patient (or to the parent or B Vaccines legal representative in the case of a DATES: Beginning no later than AGENCY: Centers for Disease Control and November 1, 2016, each health care child) receiving vaccines covered under Prevention (CDC), Department of Health provider who administers hepatitis A or the National Vaccine Injury and Human Services (HHS). hepatitis B vaccine to any child or adult Compensation Program (VICP). mstockstill on DSK3G9T082PROD with NOTICES ACTION: Notice. in the United States shall provide copies Development and revision of the of the relevant vaccine information vaccine information materials, also SUMMARY: Under the National materials referenced in this notice, in known as Vaccine Information Childhood Vaccine Injury Act (NCVIA) conformance with the August 9, 2016 Statements (VIS), have been delegated (42 U.S.C. 300aa–26), CDC must develop CDC Instructions for the Use of Vaccine by the Secretary to the Centers for vaccine information materials that all Information Statements prior to Disease Control and Prevention (CDC). health care providers are required to providing such vaccinations. Section 2126 requires that the materials VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1


Document Created: 2018-02-09 13:12:27
Document Modified: 2018-02-09 13:12:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before November 7, 2016.
ContactLeroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.
FR Citation81 FR 62138 
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