83 FR 26464 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 110 (June 7, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26464-26465 | |
| FR Document | 2018-12251 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26464-26465] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12251] [[Page 26464]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18AFX; Docket No. CDC-2018-0052] Proposed Data Collection 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Traumatic Brain Injury Disparities in Rural Areas (TBIDRA). This study will conduct a formative research to understand the challenges that rural healthcare providers face when diagnosing, treating, and managing traumatic brain injury (TBI) and develop a knowledge base to address gaps in services to improve clinical care and TBI outcomes in rural communities. DATES: CDC must receive written comments on or before August 6, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0052 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. 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, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project Traumatic Brain Injury Disparities in Rural Areas (TBIDRA)--New-- National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Traumatic Brain Injury (TBI) is a significant public health concern in the United States, research indicates that residents of rural areas have both higher incidence and higher mortality rates from TBI than do residents of urban areas, and that the prevalence of TBI-related disability in rural geographical areas is higher than in urban and suburban areas. The obstacles healthcare providers and patients face in rural areas are vastly different than those in urban areas. There is little published research specifically related to the challenges rural providers face in TBI diagnosis and treatment, and even less examination into effective ways to address gaps in service and improve TBI outcomes. The National Center for Injury Prevention and Control at the CDC, in a 2015 ``Report to Congress on TBI in the United States,'' determined that certain population groups, including residents of rural geographic areas, require special consideration when it comes to researching TBI. This is a new Information Collection Request for 2 years to collect information on challenges that rural healthcare providers face in diagnosing, treating, and managing TBI of all severities and develop a knowledge base upon which we can begin to address gaps in services to improve clinical care and TBI outcomes in rural communities. The target population for the data collection effort includes physicians, nurse practitioners (NPs), and physician assistants (PAs) in selected specialties (general or family practice, emergency medicine, pediatrics) working in direct patient care in rural and urban areas. The focus of the study is rural healthcare providers; urban healthcare providers will be included in this study to allow for comparison in identifying the distinct challenges and opportunities for rural healthcare providers. This study has two data collection methods. A web survey to gather quantitative data on the unique challenges faced by rural clinicians, and focus groups to gain deeper insight into the context supporting and/or inhibiting access to comprehensive TBI evaluation and treatment, the study will collect qualitative data through focus groups with rural clinicians. The proposed information collection is authorized by the Public Health Services Act (PHS Act) which provides the legislative means for states to advance public health across the lifespan and to reduce health disparities. The total estimated annualized burden hours is 200. There are no costs to respondents other than their time. [[Page 26465]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in (in hours) respondent hours) ---------------------------------------------------------------------------------------------------------------- Health care providers (Primary TBI Provider 600 1 15/60 150 Care Physician, Emergency Survey. Physician, Nurse Practitioner and Physician Assistant). Focus group 36 1 5/60 3 screener. Focus group 31 1 5/60 3 questionnaire. Focus group 31 1 85/60 44 discussion guide. --------------------------------------------------------------------------------- Total..................... ................ .............. .............. .............. 200 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting 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. 2018-12251 Filed 6-6-18; 8:45 am] BILLING CODE 4163-18-P
![26464 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
DEPARTMENT OF HEALTH AND instruments, contact Jeffery M. Zirger, incidence and higher mortality rates
HUMAN SERVICES Information Collection Review Office, from TBI than do residents of urban
Centers for Disease Control and areas, and that the prevalence of TBI-
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS– related disability in rural geographical
Prevention D74, Atlanta, Georgia 30329; phone: areas is higher than in urban and
[60Day–18–18AFX; Docket No. CDC–2018– 404–639–7570; Email: omb@cdc.gov. suburban areas. The obstacles
0052] SUPPLEMENTARY INFORMATION: Under the healthcare providers and patients face
Paperwork Reduction Act of 1995 (PRA) in rural areas are vastly different than
Proposed Data Collection Submitted (44 U.S.C. 3501–3520), Federal agencies those in urban areas. There is little
for Public Comment and must obtain approval from the Office of published research specifically related
Recommendations Management and Budget (OMB) for each to the challenges rural providers face in
collection of information they conduct TBI diagnosis and treatment, and even
AGENCY: Centers for Disease Control and less examination into effective ways to
Prevention (CDC), Department of Health or sponsor. In addition, the PRA also
requires Federal agencies to provide a address gaps in service and improve TBI
and Human Services (HHS). outcomes. The National Center for
60-day notice in the Federal Register
ACTION: Notice with comment period. Injury Prevention and Control at the
concerning each proposed collection of
information, including each new CDC, in a 2015 ‘‘Report to Congress on
SUMMARY: The Centers for Disease
proposed collection, each proposed TBI in the United States,’’ determined
Control and Prevention (CDC), as part of
extension of existing collection of that certain population groups,
its continuing effort to reduce public
information, and each reinstatement of including residents of rural geographic
burden and maximize the utility of
previously approved information areas, require special consideration
government information, invites the
collection before submitting the when it comes to researching TBI.
general public and other Federal
agencies the opportunity to comment on collection to the OMB for approval. To This is a new Information Collection
a proposed and/or continuing comply with this requirement, we are Request for 2 years to collect
information collection, as required by publishing this notice of a proposed information on challenges that rural
the Paperwork Reduction Act of 1995. data collection as described below. healthcare providers face in diagnosing,
This notice invites comment on a The OMB is particularly interested in treating, and managing TBI of all
proposed information collection project comments that will help: severities and develop a knowledge base
titled Traumatic Brain Injury Disparities 1. Evaluate whether the proposed upon which we can begin to address
in Rural Areas (TBIDRA). This study collection of information is necessary gaps in services to improve clinical care
will conduct a formative research to for the proper performance of the and TBI outcomes in rural communities.
understand the challenges that rural functions of the agency, including The target population for the data
healthcare providers face when whether the information will have collection effort includes physicians,
diagnosing, treating, and managing practical utility; nurse practitioners (NPs), and physician
traumatic brain injury (TBI) and develop 2. Evaluate the accuracy of the assistants (PAs) in selected specialties
a knowledge base to address gaps in agency’s estimate of the burden of the (general or family practice, emergency
services to improve clinical care and proposed collection of information, medicine, pediatrics) working in direct
TBI outcomes in rural communities. including the validity of the patient care in rural and urban areas.
methodology and assumptions used; The focus of the study is rural
DATES: CDC must receive written
3. Enhance the quality, utility, and healthcare providers; urban healthcare
comments on or before August 6, 2018. clarity of the information to be providers will be included in this study
ADDRESSES: You may submit comments, collected; and to allow for comparison in identifying
identified by Docket No. CDC–2018– 4. Minimize the burden of the the distinct challenges and
0052 by any of the following methods: collection of information on those who opportunities for rural healthcare
• Federal eRulemaking Portal: are to respond, including through the providers. This study has two data
Regulations.gov. Follow the instructions use of appropriate automated, collection methods. A web survey to
for submitting comments. electronic, mechanical, or other
• Mail: Jeffrey M. Zirger, Information gather quantitative data on the unique
technological collection techniques or challenges faced by rural clinicians, and
Collection Review Office, Centers for other forms of information technology,
Disease Control and Prevention, 1600 focus groups to gain deeper insight into
e.g., permitting electronic submissions the context supporting and/or inhibiting
Clifton Road NE, MS–D74, Atlanta, of responses.
Georgia 30329. access to comprehensive TBI evaluation
5. Assess information collection costs. and treatment, the study will collect
Instructions: All submissions received
must include the agency name and Proposed Project qualitative data through focus groups
Docket Number. CDC will post, without with rural clinicians.
Traumatic Brain Injury Disparities in
change, all relevant comments to Rural Areas (TBIDRA)—New—National The proposed information collection
Regulations.gov. Center for Injury Prevention and Control is authorized by the Public Health
Please note: Submit all comments (NCIPC), Centers for Disease Control Services Act (PHS Act) which provides
through the Federal eRulemaking portal and Prevention (CDC). the legislative means for states to
(regulations.gov) or by U.S. mail to the advance public health across the
address listed above. Background and Brief Description lifespan and to reduce health
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: To Traumatic Brain Injury (TBI) is a disparities.
request more information on the significant public health concern in the The total estimated annualized
proposed project or to obtain a copy of United States, research indicates that burden hours is 200. There are no costs
the information collection plan and residents of rural areas have both higher to respondents other than their time.
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![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26465
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)
Health care providers (Primary Care TBI Provider Survey ......................... 600 1 15/60 150
Physician, Emergency Physician,
Nurse Practitioner and Physician
Assistant).
Focus group screener ...................... 36 1 5/60 3
Focus group questionnaire .............. 31 1 5/60 3
Focus group discussion guide ......... 31 1 85/60 44
Total ........................................... ........................................................... ........................ ........................ ........................ 200
Jeffrey M. Zirger, instructions for submitting comments. https://www.regulations.gov or at the
Acting Chief, Information Collection Review Comments submitted electronically, Dockets Management Staff between 9
Office, Office of Scientific Integrity, Office including attachments, to https:// a.m. and 4 p.m., Monday through
of the Associate Director for Science, Office www.regulations.gov will be posted to Friday. FDA will consider any
of the Director, Centers for Disease Control the docket unchanged. Because your comments received in determining
and Prevention. comment will be made public, you are whether to amend the current listing of
[FR Doc. 2018–12251 Filed 6–6–18; 8:45 am] solely responsible for ensuring that your modifications to the list of recognized
BILLING CODE 4163–18–P comment does not include any standards, Recognition List Number:
confidential information that you or a 049.
third party may not wish to be posted, • Confidential Submissions—To
DEPARTMENT OF HEALTH AND such as medical information, your or submit a comment with confidential
HUMAN SERVICES anyone else’s Social Security number, or information that you do not wish to be
confidential business information, such made publicly available, submit your
Food and Drug Administration comments only as a written/paper
as a manufacturing process. Please note
[Docket No. FDA–2004–N–0451] that if you include your name, contact submission. You should submit two
information, or other information that copies total. One copy will include the
Food and Drug Administration identifies you in the body of your information you claim to be confidential
Modernization Act of 1997: comments, that information will be with a heading or cover note that states
Modifications to the List of Recognized posted on https://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS
Standards, Recognition List Number: • If you want to submit a comment CONFIDENTIAL INFORMATION’’. The
049 with confidential information that you Agency will review this copy, including
do not wish to be made available to the the claimed confidential information, in
AGENCY: Food and Drug Administration, its consideration of comments. The
public, submit the comment as a
HHS. second copy, which will have the
written/paper submission and in the
ACTION: Notice. manner detailed (see ‘‘Written/Paper claimed confidential information
Submissions’’ and ‘‘Instructions’’). redacted/blacked out, will be available
SUMMARY: The Food and Drug for public viewing and posted on
Administration (FDA or Agency) is Written/Paper Submissions https://www.regulations.gov. Submit
announcing a publication containing Submit written/paper submissions as both copies to the Dockets Management
modifications the Agency is making to follows: Staff. If you do not wish your name and
the list of standards FDA recognizes for • Mail/Hand delivery/Courier (for contact information to be made publicly
use in premarket reviews (FDA written/paper submissions): Dockets available, you can provide this
Recognized Consensus Standards). This Management Staff (HFA–305), Food and information on the cover sheet and not
publication, entitled ‘‘Modifications to Drug Administration, 5630 Fishers in the body of your comments and you
the List of Recognized Standards, Lane, Rm. 1061, Rockville, MD 20852. must identify this information as
Recognition List Number: 049’’ • For written/paper comments ‘‘confidential.’’ Any information marked
(Recognition List Number: 049), will submitted to the Dockets Management as ‘‘confidential’’ will not be disclosed
assist manufacturers who elect to Staff, FDA will post your comment, as except in accordance with 21 CFR 10.20
declare conformity with consensus well as any attachments, except for and other applicable disclosure law. For
standards to meet certain requirements information submitted, marked and more information about FDA’s posting
for medical devices. identified, as confidential, if submitted of comments to public dockets, see 80
DATES: These modifications to the list of as detailed in ‘‘Instructions.’’ FR 56469, September 18, 2015, or access
recognized standards are applicable Instructions: All submissions received the information at: https://www.gpo.gov/
June 7, 2018. must include the Docket No. FDA– fdsys/pkg/FR-2015-09-18/pdf/2015-
2004–N–0451 for ‘‘Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit comments 23389.pdf.
as follows: Administration Modernization Act of Docket: For access to the docket to
1997: Modifications to the List of read background documents or the
Electronic Submissions Recognized Standards, Recognition List electronic and written/paper comments
Submit electronic comments in the Number: 049.’’ Received comments will received, go to https://
following way: be placed in the docket and, except for www.regulations.gov and insert the
• Federal eRulemaking Portal: those submitted as ‘‘Confidential docket number, found in brackets in the
https://www.regulations.gov. Follow the Submissions,’’ publicly viewable at heading of this document, into the
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Document Created: 2018-06-07 00:49:48
Document Modified: 2018-06-07 00:49:48
| 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 | CDC must receive written comments on or before August 6, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 26464 |
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