81 FR 96457 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 251 (December 30, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 251 (December 30, 2016)
| Page Range | 96457-96459 | |
| FR Document | 2016-31740 |
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)] [Notices] [Pages 96457-96459] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31740] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-1074; Docket No. CDC-2016-0123] 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 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 required by the Paperwork Reduction Act of 1995. This notice invites comment on the revision of the information collection entitled ``Colorectal Cancer Control Program (CRCCP) Monitoring Activities.'' The change to the collection will include a [[Page 96458]] redesigned survey and a redesigned clinic-level data collection template. DATES: Written comments must be received on or before February 28, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0123 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions 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 Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted 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 the 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 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; (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 Colorectal Cancer Control Program (CRCCP) Monitoring Activities-- (OMB Control No. 0920-1074, exp. 6/30/2018)--Revision--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is requesting a revision of the information collection approved under OMB Control Number 0920-1074. Based on feedback from grantees and internal subject matter experts, CDC proposes use of a revised annual grantee survey instrument, as well as a revised clinic-level data collection template. The number of respondents will also decrease from 31 to 30 grantees. Total estimated annualized burden will decrease. OMB approval is requested for three years. Colorectal cancer (CRC) is the second leading cause of death from cancer in the United States among cancers that affect both men and women. CRC screening has been shown to reduce incidence of and death from the disease. Screening for CRC can detect disease early when treatment is more effective and prevent cancer by finding and removing precancerous polyps. Of individuals diagnosed with early stage CRC, more than 90% live five or more years. Despite strong evidence supporting screening, only 65% of adults currently report being up-to- date with CRC screening as recommended by the U.S. Preventive Services Task Force, with more than 22 million age-eligible adults estimated to be untested. To reduce CRC morbidity, mortality, and associated costs, use of CRC screening tests must be increased among age-eligible adults with the lowest CRC screening rates. CDC's Colorectal Cancer Control Program (CRCCP) currently provides funding to 30 grantees under ``Organized Approaches to Increase Colorectal Cancer Screening'' (CDC-RFA-DP15-1502). CRCCP grantees include state governments or bona-fide agents, universities, and tribal organizations. The purpose of the cooperative agreement program is to increase CRC screening rates among an applicant defined target population of persons 50-75 years of age within a partner health system serving a defined geographical area or disparate population. The CDC significantly redesigned the CRCCP in 2015. The CRCCP has two components. Component 1: Funding for component 1 is limited to partnerships with health systems to implement up to four priority evidence-based interventions (EBIs) described in the Guide to Community Preventive Services as well as other supporting strategies. Grantees must implement at least two EBIs in each partnering health system. All 30 CRCCP grantees received Component 1 funding. Component 2: Funding for component 2 is used by grantees to provide direct screening and follow-up clinical services for a limited number of individuals aged 50-64 in the program's priority population who are asymptomatic, at average risk for CRC, have inadequate or no health insurance for CRC screening, and are low income. Six of the 30 CRCCP grantees received Component 2 funding. Two forms of data collection have been implemented to assess program processes and outcomes. In Program Year 1, the annual grantee survey monitored grantee program implementation, including (1) program management, (2) implementation of the EBIs and Supporting Activities (SAs) (3) health information technology (IT), (4) partnerships, (5) data use, (6) training and technical assistance (TA), and (7) clinical service delivery (for programs receiving Component 2 funding only). Clinic-level data collection assessed CRCCP's primary outcome of interest--CRC screening rates within partner health systems--by measuring the following components: (1) Partner health system, clinic, and patient population characteristics, (2) reporting period (for screening rates), (3) Chart review screening rate data, (4) Electronic Health Record (EHR) [[Page 96459]] screening rate, and (5) Priority evidence-based EBIs and SAs. CRCCP grantees collected and reported CRCCP clinic-level information for all partnering health system primary care clinic sites. For Program Years 2-5, based on feedback from grantees, CDC proposes use of updated data collection instruments. Specifically, CDC plans to implement a revised CRCCP annual grantee survey that eliminates survey items related to implementation of EBIs and SAs as these data are more accurately reported at the clinic level. Conversely, CDC plans to implement a revised CRCCP clinic-level data collection template that includes additional data variables related to implementation of EBIs and SAs, as well as monitoring and evaluation activities, at the clinic level. Redesigned data elements will enable CDC to better gauge progress in meeting CRCCP program goals and monitor implementation activities, evaluate outcomes, and identify grantee technical assistance needs. In addition, data collected will inform program improvement and help identify successful activities that need to be maintained, replicated, or expanded. OMB approval is requested for three years. The number of grantees decreased from 31 grantees in program year one to 30 grantees in program year two. In addition, the total estimated annualized burden hours have decreased from 210 to 204 hours. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response Total burden respondents respondent (in hours) (in hours) ---------------------------------------------------------------------------------------------------------------- CRCCP Grantees................ CRCCP Annual 30 1 24/60 12 Grantee Survey. CRCCP Clinic- 30 12 32/60 192 level Information Collection Template. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 204 ---------------------------------------------------------------------------------------------------------------- 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. 2016-31740 Filed 12-29-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96457
collected; (d) ways to minimize the and Response Act of 2002, (42 U.S.C. adopted an identical system to collect
burden of the collection of information 262a), requires the United States information for the possession, use, and
on respondents, including through the Department of Health and Human transfer of select agents and toxins.
use of automated collection techniques Services (HHS) to regulate the CDC is requesting OMB approval to
or other forms of information possession, use, and transfer of revise the collected information under
technology; and (e) estimates of capital biological agents or toxins that have the the select agent regulations through the
or start-up costs and costs of operation, potential to pose a severe threat to use of the APHIS/CDC Form 3 (Report
maintenance, and purchase of services public health and safety (select agents of Theft, Loss, or Release of Select
to provide information. Burden is the and toxins). Subtitle B of the Public Agents and Toxins). The Report of
total time, effort, or financial resources Health Security and Bioterrorism Theft, Loss, or Release of Select Agent
expended by persons to generate, Preparedness and Response Act of 2002 and Toxin form (42 CFR 73.19(a),(b))
maintain, retain, disclose, or provide (which may be cited as the Agricultural must be completed by an individual or
information to or for a Federal agency. Bioterrorism Protection Act of 2002), (7 an entity whenever the individual or
This includes the time needed to review U.S.C. 8401), requires the United States entity experiences a theft, loss, or
instructions; to develop, acquire, install Department of Agriculture (USDA) to release of a select agent or toxin.
and utilize technology and systems for regulate the possession, use, and
transfer of biological agents or toxins CDC is proposing to revise the form to
the purpose of collecting, validating and further clarify what needs to be reported
verifying information, processing and that have the potential to pose a severe
threat to animal or plant health, or as a ‘‘release’’ and ‘‘loss’’ and additional
maintaining information, and disclosing fields to assist with categorizing the
and providing information; to train animal or plant products (select agents
and toxins). The HHS Secretary type of release (e.g., spill within
personnel to respond to a collection of secondary containment, occupational
information, search data sources, and delegated the responsibility for
promulgating and implementing select exposure, possible breach of facility
complete and review the collection of containment, etc.), type of exposure,
information; and to transmit or agent regulations found at 42 CFR part
73 to CDC Division of Select Agents and and the understanding of safety and
otherwise disclose the information. security risk levels relative to human
Toxins (DSAT). The Animal and Plant
Proposed Project Health Inspection Service (APHIS)/ illness. Estimated average time to
Possession, Use, and Transfer of Agriculture Select Agent Services complete this form is one hour.
Select Agents and Toxins (42 CFR 73) (AgSAS) was delegated responsibility by The total estimated annualized
(OMB Control No. 0920–0576, exp. 12/ USDA for select agent regulations (7 burden for this collection was
31/2018)—Revision—Office of Public CFR part 331, and 9 CFR part 121). The calculated using data obtained from the
Health Preparedness and Response Federal Select Agent Program (FSAP) is FSAP database and is estimated as 430
(OPHPR), Centers for Disease Control the collaboration of the DSAT and hours. Information will be collected via
and Prevention (CDC). AgSAS to administer the select agent fax, email and hard copy mail from
regulations in a manner to minimize the respondents. Upon OMB approval, CDC
Background and Brief Description administrative burden on persons will continue use of the revised form
Subtitle A of the Public Health subject to the select agent regulations. through November 2018. There is no
Security and Bioterrorism Preparedness Accordingly, CDC and APHIS have cost to the respondents.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response hours
respondent (in hours)
73.19 Section ................. Report of Theft, Loss, or Release of Select 215 1 2 430
Agents and Toxins.
Total ........................ .............................................................................. ........................ ........................ ........................ 430
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Disease
Chief, Information Collection Review Office, HUMAN SERVICES Control and Prevention (CDC), as part of
Office of Scientific Integrity, Office of the its continuing efforts to reduce public
Associate Director for Science, Office of the Centers for Disease Control and burden and maximize the utility of
Director, Centers for Disease Control and Prevention government information, invites the
Prevention. general public and other Federal
[FR Doc. 2016–31739 Filed 12–29–16; 8:45 am] [60Day–17–1074; Docket No. CDC–2016– agencies to take this opportunity to
BILLING CODE 4163–18–P 0123] comment on proposed and/or
continuing information collections, as
Proposed Data Collection Submitted
required by the Paperwork Reduction
for Public Comment and
srobinson on DSK5SPTVN1PROD with NOTICES
Recommendations Act of 1995. This notice invites
comment on the revision of the
AGENCY: Centers for Disease Control and information collection entitled
Prevention (CDC), Department of Health ‘‘Colorectal Cancer Control Program
and Human Services (HHS). (CRCCP) Monitoring Activities.’’ The
change to the collection will include a
ACTION: Notice with comment period.
VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1](https://thefederalregister.org/doc/81_FR_96708/page/1.svg)
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96459
screening rate, and (5) Priority evidence- accurately reported at the clinic level. assistance needs. In addition, data
based EBIs and SAs. CRCCP grantees Conversely, CDC plans to implement a collected will inform program
collected and reported CRCCP clinic- revised CRCCP clinic-level data improvement and help identify
level information for all partnering collection template that includes successful activities that need to be
health system primary care clinic sites. additional data variables related to maintained, replicated, or expanded.
For Program Years 2–5, based on implementation of EBIs and SAs, as OMB approval is requested for three
feedback from grantees, CDC proposes well as monitoring and evaluation years. The number of grantees decreased
use of updated data collection activities, at the clinic level. from 31 grantees in program year one to
instruments. Specifically, CDC plans to Redesigned data elements will enable 30 grantees in program year two. In
implement a revised CRCCP annual CDC to better gauge progress in meeting addition, the total estimated annualized
grantee survey that eliminates survey CRCCP program goals and monitor burden hours have decreased from 210
items related to implementation of EBIs implementation activities, evaluate to 204 hours. There are no costs to
and SAs as these data are more outcomes, and identify grantee technical respondents other than their time.
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)
CRCCP Grantees ............................. CRCCP Annual Grantee Survey ...... 30 1 24/60 12
CRCCP Clinic-level Information Col- 30 12 32/60 192
lection Template.
Total ........................................... ........................................................... ........................ ........................ ........................ 204
Leroy A. Richardson, paper-based processes in keeping with U.S. Customs and Border Protection and
Chief, Information Collection Review Office, Federal policy and improve operations its Partner Government Agencies (PGAs)
Office of Scientific Integrity, Office of the to further assist HHS/CDC’s mission to relating to the import or export of cargo
Associate Director for Science, Office of the protect public health. through a ‘‘single window’’ concept.
Director, Centers for Disease Control and CBP has developed ACE as the single
DATES: This action is effective December
Prevention. window for the trade community to
30, 2016.
[FR Doc. 2016–31740 Filed 12–29–16; 8:45 am] transmit electronically all required
FOR FURTHER INFORMATION CONTACT: For
BILLING CODE 4163–18–P
information regarding this Notice: cargo-related information.
Ashley A. Marrone, J.D., Division of This notice announces HHS/CDC’s
DEPARTMENT OF HEALTH AND Global Migration and Quarantine, updated policy concerning the
HUMAN SERVICES Centers for Disease Control and electronic transmission of HHS/CDC
Prevention, 1600 Clifton Road NE., MS– permits, forms, and documents using
Centers for Disease Control and E03, Atlanta, GA 30329. For information CBP’s Document Image System (DIS).
Prevention regarding CDC operations related to this This DIS capability will satisfy the
Notice: Kendra Stauffer, D.V.M., HHS/CDC data and electronic document
Electronic Filing of Certain Import Data Division of Global Migration and requirements for any entry filed
Into the Document Image System Quarantine, Quarantine and Border electronically in ACE and enable the
Through the Automated Commercial Health Services Branch, Importations trade community to have a CBP-
Environment and Animal Contact Team, Centers for managed single window for the
AGENCY: Centers for Disease Control and Disease Control and Prevention, 1600 electronic submission of data and
Prevention, Department of Health and Clifton Road NE., MS–E28, Atlanta, GA documents required by HHS/CDC
Human Services. 30345. Either may also be reached by during the cargo importation and review
telephone 404–498–1600 or email process. The list of PGA forms and
ACTION: Notice.
CDCAnimalImports@cdc.gov. documents, including documents
SUMMARY: Through publication of this SUPPLEMENTARY INFORMATION: required by HHS/CDC, which may be
notice, the Centers for Disease Control transmitted using DIS may be found at
and Prevention (CDC) located within the I. Background http://www.cbp.gov/trade/ace/features
Department of Health and Human On February 19, 2014, the President under the DIS tab by clicking on the
Services (HHS) announces a new policy signed Executive Order 13659, ‘‘ACE PGA Forms List’’ hyperlink in the
and guidance for the electronic Streamlining the Export/Import Process ‘‘References’’ column. The HHS/CDC
submission of data related to the for America’s Businesses (79 FR 10655), permits, forms, and documents listed in
importation of CDC-regulated items in that requires the completion and the ACE PGA Forms List are those
the International Trade Data System government-wide utilization by eligible to be transmitted using DIS.
(ITDS). Certain data, forms, and December 31, 2016 of the International
srobinson on DSK5SPTVN1PROD with NOTICES
II. Current HHS/CDC Paper-Based
documents required to be submitted to Trade Data System (ITDS) and Procedures
HHS/CDC will be submitted through the establishes a two-tiered governance
U.S. Customs and Border Protection process to oversee its implementation. Under current applicable HHS/CDC
(CBP)’s Automated Commercial Once fully implemented, ITDS, through policy and operations, the importation
Environment (ACE) system, using the the Automated Commercial of HHS/CDC-regulated commodities
Document Image System (DIS). This Environment (ACE), will allow into the customs territory of the United
electronic process will replace certain importers to submit the data required by States typically requires the submission
VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1](https://thefederalregister.org/doc/81_FR_96708/page/3.svg)
Document Created: 2016-12-30 05:16:29
Document Modified: 2016-12-30 05:16:29
| 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 February 28, 2017. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 | 81 FR 96457 |
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