81 FR 69530 - 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 194 (October 6, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 194 (October 6, 2016)
| Page Range | 69530-69532 | |
| FR Document | 2016-24132 |
[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)] [Notices] [Pages 69530-69532] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24132] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0733]; [Docket No. CDC-2016-0095] 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 (EDHI) Hearing and Screening Follow-up Survey. DATES: Written comments must be received on or before December 5, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0095 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 (EDHI) Hearing and Screening Follow-up Survey (OMB No. 0920-0733, Expiration 08/30/2016)-- Reinstatement with Change--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. As part of these efforts the Center is actively involved in addressing the early identification of hearing loss among newborns and infants. Congenital hearing loss is a common birth defect that affects 1 to 3 per 1,000 live births, or approximately 12,000 children across the United States annually.1 2 Studies have shown that children with a delayed diagnosis of hearing loss can experience preventable delays in speech, language, and cognitive development.3-5 To ensure children with hearing loss are identified as soon as possible, many states and United States (U.S.) territories have implemented Early Hearing Detection and Intervention (EHDI) programs and enacted laws related to infant hearing screening. The majority of these EHDI programs have adopted the ``1-3-6'' plan, which consists of three core goals: (1) Screening all infants for hearing loss before 1 month of age, (2) ensuring diagnostic audiologic evaluation before 3 months of age for those who do not pass the screening, and (3) enrollment in early intervention services before 6 months of age for those identified with hearing loss. Federal support for identifying children with hearing loss began with the Children's Health Act of 2000, which authorized federal programs to support EHDI activities at the state level. Since then, funds have been distributed to states via cooperative agreements from the CDC and grants from the Health Resources and Services Administration (HRSA). States are using these federal monies to enhance EHDI programs and develop corresponding tracking and surveillance systems. These systems are intended to help EHDI programs ensure infants and children are receiving recommended [[Page 69531]] hearing screening, follow-up, and intervention services. The CDC's NCBDDD will fund this work to obtain standardized annual jurisdictional data related to the number of children screened for hearing loss, referred for and receiving follow-up testing (e.g., diagnostic audiologic evaluation). As with the original and reinstated information collection the overall purpose of this updated survey is to consistently gather the aggregate-level data required to assess progress toward the National EHDI Goals. Proposed changes for the updated survey have been made in response to feedback from respondents and requests for additional information from state and national partners. These updates are intended to further increase the standardization and completeness of the data collected and make the survey easier to complete. These changes include adding new fields to capture data about hearing screening conducted by using one- stage, two-stage, or blended (both one-stage and two-stage) screening protocol. In addition, fields were added to be able to report the number of occurring homebirths and the number of infants not documented to have received recommended screening, diagnostic and/or intervention services, due to reasons such as the infant being adopted, no referral from the Primary Care Physician (PCP)/Ear-Nose-Throat (ENT) specialist and/or due to medical reasons. Several fields have been removed in order to improve data quality and better evaluate whether jurisdictions are meeting the nationwide benchmarks. The table for reporting type and severity of hearing loss data has been updated so that this data can be reported using only the classification system from the American Speech and Hearing Association (ASHA). The table for reporting demographics has also been updated to include fewer columns, in order to improve data quality and data standardization with the previous sections of the survey. The collected data will continue to be used in four key ways. First, it will be used to determine annual rates of hearing screening, referral for further diagnostic testing, loss to follow-up, incidence of hearing loss in infants, and enrollment in early intervention. These data will assist in determining if infants and children are receiving recommended EHDI-related services in a timely fashion. The information is intended to be made available through presentations, articles related to EHDI programs and infant hearing loss, and online at: www.cdc.gov/ncbddd/hearingloss/ehdi-data.html. Second, the data will be used to determine rates of loss to follow- up within different stages of the EHDI process. Aggregated information about maternal race, ethnicity, education, and age will be used to help determine whether rates of loss to follow-up are correlated with any of these demographic variables. As with the most recent reinstatement with change (2013), the updated survey will continue to use same set of demographic data items, which will make it possible to continue analyzing the association between factors such as maternal race and loss to follow-up, maintain comparability between previous and future data, and minimize burden on respondents by continuing to request the same data that programs are currently collecting and able to report. This information is anticipated to continue to be important in developing methods to help minimize loss to follow-up so all children receive recommended hearing-related services in a timely manner. Third, the data will be helpful in determining to what extent jurisdictional tracking and surveillance systems are capturing essential information related to follow-up services, identification, and enrollment in early intervention. It will also be used by CDC EHDI to identify areas in jurisdictional EHDI systems that may require additional modification. This is anticipated to be helpful in providing technical support to funded jurisdictions as well as for assessing the impact of federal initiatives related to hearing loss in infants and children. Fourth, the requested data will aid in efforts to determine the prevalence of differing degrees of hearing loss (e.g., mild, severe, profound, etc.) among infants and children. Information provided by this updated survey also has the potential to be used for other purposes. These include quality improvement activities by jurisdictional EHDI programs (e.g., identifying areas within the EHDI processes that could benefit from further development) and providing requested data for Healthy People 2020, Objective ENT- VSL-1 on newborn hearing screening, evaluation, and intervention. In addition, the aggregate-level data will continue to be made available online to other state and federal agencies, organizations, and the general public. The total burden hours is 238. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- EHDI Program State Program Survey 59 1 10/60 10 Coordinators Contacted......... Directions EHDI Program State Program Survey 57 1 240/60 228 Coordinators who return the survey......................... ------------------------------------------------------------------------------- Totals...................... .............. .............. .............. .............. 238 ---------------------------------------------------------------------------------------------------------------- [[Page 69532]] 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. 2016-24132 Filed 10-5-16; 8:45 am] BILLING CODE 4163-18-P
![69530 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices
indicated or the offices of the Board of Prevention, 1600 Clifton Road NE., MS– the collection of information; and to
Governors not later than October 31, D74, Atlanta, Georgia 30329. transmit or otherwise disclose the
2016. Instructions: All submissions received information.
A. Federal Reserve Bank of Boston must include the agency name and
Proposed Project
(Prabal Chakrabarti, Senior Vice Docket Number. All relevant comments
President) 600 Atlantic Avenue, Boston, received will be posted without change Early Hearing Detection and
Massachusetts 02210–2204. Comments to Regulation.gov, including any Intervention (EDHI) Hearing and
can also be sent electronically to personal information provided. For Screening Follow-up Survey (OMB No.
BOS.SRC.Applications.Comments@ access to the docket to read the 0920–0733, Expiration 08/30/2016)—
bos.frb.org: background documents or comments Reinstatement with Change—National
1. TCT Holdings Inc., Teachers received, go to Regulations.gov. Center on Birth Defects and
Insurance and Annuity Association of FOR FURTHER INFORMATION CONTACT:
Developmental Disabilities (NCBDDD),
America and TIAA Board of Overseers, Leroy A. Richardson, Information Centers for Disease Control and
all of New York, New York; to acquire Collection Review Office, Centers for Prevention (CDC).
EverBank Financial Corp and thereby Disease Control and Prevention, 1600 Background and Brief Description
indirectly acquire EverBank, both of Clifton Road NE., MS–D74, Atlanta, The Division of Human Development
Jacksonville, Florida. Georgia 30329. and Disability, located within NCBDDD,
Board of Governors of the Federal Reserve SUPPLEMENTARY INFORMATION: Under the promotes the health of babies, children,
System, October 3, 2016. Paperwork Reduction Act of 1995 (PRA) and adults, with a focus on preventing
Michele Taylor Fennell, (44 U.S.C. 3501–3520), Federal agencies birth defects and developmental
Assistant Secretary of the Board. must obtain approval from the Office of disabilities and optimizing the health
[FR Doc. 2016–24221 Filed 10–5–16; 8:45 am] Management and Budget (OMB) for each outcomes of those with disabilities. As
BILLING CODE 6210–01–P
collection of information they conduct part of these efforts the Center is
or sponsor. In addition, the PRA also actively involved in addressing the early
requires Federal agencies to provide a identification of hearing loss among
60-day notice in the Federal Register newborns and infants. Congenital
DEPARTMENT OF HEALTH AND concerning each proposed collection of hearing loss is a common birth defect
HUMAN SERVICES information, and each reinstatement of that affects 1 to 3 per 1,000 live births,
previously approved information or approximately 12,000 children across
Centers for Disease Control and collection before submitting the collect the United States annually.1 2 Studies
Prevention to OMB for approval. To comply with have shown that children with a
[60Day–16–0733]; [Docket No. CDC–2016– this requirement, we are publishing this delayed diagnosis of hearing loss can
0095] notice of a proposed data collection as experience preventable delays in
described below. speech, language, and cognitive
Proposed Data Collections Submitted Comments are invited on: (a) Whether development.3–5 To ensure children
for Public Comment and the proposed collection of information with hearing loss are identified as soon
Recommendations is necessary for the proper performance as possible, many states and United
of the functions of the agency, including States (U.S.) territories have
AGENCY: Centers for Disease Control and whether the information shall have implemented Early Hearing Detection
Prevention (CDC), Department of Health practical utility; (b) the accuracy of the and Intervention (EHDI) programs and
and Human Services (HHS) agency’s estimate of the burden of the enacted laws related to infant hearing
ACTION: Notice with comment period proposed collection of information; (c) screening. The majority of these EHDI
ways to enhance the quality, utility, and programs have adopted the ‘‘1–3–6’’
SUMMARY: The Centers for Disease clarity of the information to be plan, which consists of three core goals:
Control and Prevention (CDC), as part of collected; and (d) ways to minimize the (1) Screening all infants for hearing loss
its continuing efforts to reduce public burden of the collection of information before 1 month of age, (2) ensuring
burden and maximize the utility of on respondents, including through the diagnostic audiologic evaluation before
government information, invites the use of automated collection techniques 3 months of age for those who do not
general public and other Federal or other forms of information pass the screening, and (3) enrollment
agencies to take this opportunity to technology; and (e) estimates of capital in early intervention services before 6
comment on proposed and/or or start-up costs and costs of operation, months of age for those identified with
continuing information collections, as maintenance, and purchase of services hearing loss.
requires by the Paperwork Reduction to provide information. Burden means Federal support for identifying
Act of 1995. This notice invites the total time, effort, or financial children with hearing loss began with
comments on Early Hearing Detection resources expended by persons to the Children’s Health Act of 2000,
and Intervention (EDHI) Hearing and generate, maintain, retain, disclose or which authorized federal programs to
Screening Follow-up Survey. provide information to or for a Federal support EHDI activities at the state
DATES: Written comments must be agency. This includes the time needed level. Since then, funds have been
received on or before December 5, 2016. to review instructions; to develop, distributed to states via cooperative
ADDRESSES: You may submit comments, acquire, install and utilize technology agreements from the CDC and grants
identified by Docket No. CDC–2016– and systems for the purpose of from the Health Resources and Services
sradovich on DSK3GMQ082PROD with NOTICES
0095 by any of the following methods: collecting, validating and verifying Administration (HRSA). States are using
• Federal eRulemaking Portal: information, processing and these federal monies to enhance EHDI
Regulations.gov. Follow the instruction maintaining information, and disclosing programs and develop corresponding
for submitting comments. and providing information; to train tracking and surveillance systems.
• Mail: Leroy A. Richardson, personnel and to be able to respond to These systems are intended to help
Information Collection Review Office, a collection of information, to search EHDI programs ensure infants and
Centers for Disease Control and data sources, to complete and review children are receiving recommended
VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1](https://thefederalregister.org/doc/81_FR_69724/page/1.svg)
![69532 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices
Leroy A. Richardson wvq0sm/4W. Electronic or written those submitted as ‘‘Confidential
Chief, Information Collection Review Office, comments regarding scientific and Submissions,’’ publicly viewable at
Office of Scientific Integrity, Office of the technical issues relating to formulation http://www.regulations.gov or at the
Associate Director for Science, Office of the development and pre-market evaluation Division of Dockets Management
Director, Centers for Disease Control and of abuse-deterrent properties of opioid between 9 a.m. and 4 p.m., Monday
Prevention. drug products will be accepted until through Friday.
[FR Doc. 2016–24132 Filed 10–5–16; 8:45 am] December 1, 2016. • Confidential Submissions—To
BILLING CODE 4163–18–P ADDRESSES: The public meeting will be submit a comment with confidential
held at College Park Marriott Hotel and information that you do not wish to be
Conference Center, 3501 University made publicly available, submit your
DEPARTMENT OF HEALTH AND Blvd. East, Hyattsville, MD 20783. comments only as a written/paper
HUMAN SERVICES You may submit comments as submission. You should submit two
Food and Drug Administration follows: copies total. One copy will include the
information you claim to be confidential
[Docket No. FDA–2016–N–2896] Electronic Submissions
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Public Meeting on Pre-Market following way: CONFIDENTIAL INFORMATION.’’ The
Evaluation of Abuse-Deterrent • Federal eRulemaking Portal: http:// Agency will review this copy, including
Properties of Opioid Drug Products www.regulations.gov. Follow the the claimed confidential information, in
instructions for submitting comments. its consideration of comments. The
AGENCY: Food and Drug Administration,
Comments submitted electronically, second copy, which will have the
HHS.
including attachments, to http:// claimed confidential information
ACTION: Notice of public meeting; www.regulations.gov will be posted to
request for comments. redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http://
SUMMARY: The Food and Drug comment will be made public, you are www.regulations.gov. Submit both
Administration (FDA) is announcing a solely responsible for ensuring that your copies to the Division of Dockets
public meeting to discuss scientific and comment does not include any Management. If you do not wish your
technical issues relating to formulation confidential information that you or a name and contact information to be
development and pre-market evaluation third party may not wish to be posted, made publicly available, you can
of opioid drug products with abuse- such as medical information, your or provide this information on the cover
deterrent properties. The meeting is anyone else’s Social Security number, or sheet and not in the body of your
intended to give FDA the opportunity to confidential business information, such comments and you must identify this
discuss, and seek public input from as a manufacturing process. Please note information as ‘‘confidential.’’ Any
stakeholders on, the approach to testing that if you include your name, contact information marked as ‘‘confidential’’
FDA recommended in its draft guidance information, or other information that will not be disclosed except in
‘‘General Principles for Evaluating the identifies you in the body of your accordance with 21 CFR 10.20 and other
Abuse Deterrence of Generic Solid Oral comments, that information will be applicable disclosure law. For more
Opioid Drug Products.’’ The meeting posted on http://www.regulations.gov. information about FDA’s posting of
will also provide an opportunity to • If you want to submit a comment comments to public dockets, see 80 FR
discuss FDA’s efforts to develop with confidential information that you 56469, September 18, 2015, or access
standardized in vitro testing do not wish to be made available to the the information at: http://www.fda.gov/
methodologies for evaluating the abuse public, submit the comment as a regulatoryinformation/dockets/
deterrence of opioid drug products. FDA written/paper submission and in the default.htm.
is seeking input from all stakeholders, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
including patients, health care Submissions’’ and ‘‘Instructions’’). read background documents or the
providers, health care payers, the Written/Paper Submissions electronic and written/paper comments
pharmaceutical industry, patient Submit written/paper submissions as received, go to http://
advocates, academics, researchers, and follows: www.regulations.gov and insert the
other government entities. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
FDA may hold one or more additional written/paper submissions): Division of heading of this document, into the
meetings in the future to discuss the Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
risk-benefit paradigm for opioid drug and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
products to ensure that FDA is Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
appropriately considering the full • For written/paper comments 1061, Rockville, MD 20852.
public health impact of prescription submitted to the Division of Dockets FDA will post the agenda
opioid drug products and the post- Management, FDA will post your approximately 3 days before the public
market impact (‘‘real world effects’’) of comment, as well as any attachments, meeting at: http://www.fda.gov/Drugs/
abuse-deterrent opioid drug products. except for information submitted, NewsEvents/ucm509853.htm. FDA will
DATES: The public meeting will be held marked and identified, as confidential, also post a link to the live Webcast of
on October 31, 2016, from 8:30 a.m. to if submitted as detailed in this public meeting on the day of the
4:30 p.m. and November 1, 2016, from public meeting.
sradovich on DSK3GMQ082PROD with NOTICES
‘‘Instructions.’’
8:30 a.m. to 4 p.m. The meeting may be Instructions: All submissions received FOR FURTHER INFORMATION CONTACT:
extended or end early depending on the must include the Docket No. FDA– Michelle Eby, Center for Drug
level of public participation. Individuals 2016–N–2896 for ‘‘Public Meeting on Evaluation and Research, Food and
seeking to attend or to present at the Pre-Market Evaluation of Abuse- Drug Administration, 10903 New
meeting must register by October 17, Deterrent Properties of Opioid Drug Hampshire Ave., Bldg. 51, Rm. 6184,
2016. Please register here for the Products.’’ Received comments will be Silver Spring, MD 20993, 301–796–
meeting: http://www.cvent.com/d/ placed in the docket and, except for 4714, Michelle.Eby@fda.hhs.gov.
VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1](https://thefederalregister.org/doc/81_FR_69724/page/3.svg)
Document Created: 2016-10-06 02:37:18
Document Modified: 2016-10-06 02:37:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period | |
| Dates | Written comments must be received on or before December 5, 2016. | |
| Contact | Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329. | |
| FR Citation | 81 FR 69530 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR