80 FR 60906 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 195 (October 8, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60906-60908 | |
| FR Document | 2015-25646 |
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)] [Notices] [Pages 60906-60908] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25646] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-16-15BHH; Docket No. CDC-2016-0087] 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 Personal Protective Equipment Information (PPE-Info) Database which is a compendium of personal protective equipment (PPE) Federal regulations and consensus standards. DATES: Written comments must be received on December 7, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0087 by any of the following methods: Federal eRulemaking Portal: Regulation.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. [[Page 60907]] Proposed Project PPE-Info Database--New--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. Under Public Law 91-173 as amended by Public Law 95-164 (Federal Mine Safety and Health Act of 1977), NIOSH is proposing a three-year study to conduct research to advance the health and safety of workers. National Personal Protective Technology Laboratory (NPPTL) developed the NIOSH PPE-Info Database in response to recommendations from the Institute of Medicine (IOM) in its report, Certifying Personal Protective Technologies (PPT): Improving Worker Safety. The report recommended that NPPTL ``expand its efforts to become a national clearinghouse for information on all types of PPT.'' In its current application, the database provides standards developers, manufacturers, purchasers, and end users of PPE with a comprehensive tool which allows general or advanced criteria searches of relevant standards, target occupational groups, basic conformity assessment specifications, accredited lab information, and standard connections. The CDC is currently updating its PPE selection guidance related to the Ebola response. This guidance, Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing) (hereafter referred to as the ``CDC Ebola Response PPE Guidance'') will provide recommendations, in the form of protection standards, for PPE selection and use for the Ebola response. The NIOSH PPE-Info Database is being expanded as a tool to connect the protection standards that already exist in the database, with relevant PPE information as identified through the updated CDC Ebola Response PPE Guidance. This new aspect of the NIOSH PPE-Info Database allows end users (e.g., healthcare workers) to find products (e.g., gowns and coveralls) that are compliant (as verified by manufacturer) with the protection standards outlined by the CDC Ebola Response PPE Guidance. The initial information in the NIOSH PPE-Info Database will only offer guidance on gowns and coveralls, but is intended to expand to all PPE types associated with the official CDC Ebola Response PPE Guidance in the future. Since there is no single source of this information, NOISH is requesting that Manufactures provide it directly for input into the Ebola PPE selection guidance portion of the database. NIOSH is requesting that a Memorandum of Understanding (MOU) be developed with Ebola response PPE manufacturers to facilitate cooperation and collaboration on the provision of product information. The primary focus of the collaboration will be the exchange of manufacturer product information to be aggregated and displayed in the NIOSH PPE-Info Database. The nature and use of this information exchange includes the (1) provision of product information regarding compliance (as verified by manufacturers) with designated protection standards related to CDC guidance for personal protective equipment (PPE) used by healthcare workers during management of patients with confirmed or suspected Ebola Virus Disease (``Ebola'') and (2) the verification, by manufacturers, of product information displayed in the NIOSH PPE-Info Database. Once the MOU is signed, the manufacturer will be sent a product information sheet. Using he product information sheet, NIOSH collects manufacturer-specific product information such as; product category (e.g., gown or coverall), standards that the product claim complies with, product model number, product name, link to product specification sheet from manufacturer, and designation of whether third-party testing was performed. Once this information is completed, the product information sheet is electronically signed and returned by email to NIOSH. The NIOSH project officer will then upload the information into a PPE-Info sub database, which acts as an interim point for review. The manufacturer is then sent a link to the sub database to review their products. The manufacturer has one week to make objections. If no objections are made, the information in the sub-database gets published to the live NIOSH PPE-Info database. Quarterly, manufacturer products will be pulled from the database and sent through a pre generated product information sheet to the manufacturer POC. Manufacturers are required through the MOU to complete and return the PPE Information Sheet within two weeks of receipt along with the electronic verification form. NIOSH will be soliciting information from manufacturers and manufacturer POCs. For products that comply with gown and coverall standards, we estimate that seven manufacturers will need to supply product information. The amount of time for manufacturers to complete the initial product information sheets and make quarterly updated will be no more than 3 hours for the initial product information and one hour for the quarterly updates. The total estimated burden hours are 42. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number burden per Total Type of respondent Form name respondents responses per response (in burden respondent hours) hours ---------------------------------------------------------------------------------------------------------------- Manufacturer................... Initial Product 7 1 3 Info Sheet. Manufacturer POC............... Quarterly product 7 3 1 21 Info Sheet. ------------------------------------------------------------ Total...................... .................. .............. ............... .............. 42 ---------------------------------------------------------------------------------------------------------------- [[Page 60908]] 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. 2015-25646 Filed 10-7-15; 8:45 am] BILLING CODE 4163-18-P
![60906 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
health care, quality of life, social and ultimately, improve long-term health of takes approximately 25 minutes to
educational outcomes, and transition of adults born with CHD. complete, which includes 5 minutes to
care from childhood to adulthood. The We estimate identifying 7,500 read the informed consent and 20
information collected from this individuals with CHD in the birth minutes to answer survey questions.
population-based survey will be used to defects surveillance systems, obtaining Therefore, we estimate the total burden
inform current knowledge, allocate current addresses and sending surveys hours are 1,875.
resources, develop services, and, to 5,625 individuals with CHD (75%),
and receiving completed surveys from There are no costs to participants
4,500 individuals (80%). The survey 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 hours
respondent (in hours)
Individuals with CHD ......................... Informed consent ........................... 4,500 1 5/60 375
Individuals with CHD ......................... Survey ............................................ 4,500 1 20/60 1,500
Total ........................................... ......................................................... ........................ .......................... ........................ 1,875
Leroy A. Richardson, ADDRESSES: You may submit comments, extension of existing collection of
Chief, Information Collection Review Office, identified by Docket No. CDC–2016– information, and each reinstatement of
Office of Scientific Integrity, Office of the 0087 by any of the following methods: previously approved information
Associate Director for Science, Office of the Federal eRulemaking Portal: collection before submitting the
Director, Centers for Disease Control and Regulation.gov. Follow the instructions collection to OMB for approval. To
Prevention. for submitting comments. comply with this requirement, we are
[FR Doc. 2015–25647 Filed 10–7–15; 8:45 am] Mail: Leroy A. Richardson, publishing this notice of a proposed
BILLING CODE 4163–18–P Information Collection Review Office, data collection as described below.
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS– Comments are invited on: (a) Whether
DEPARTMENT OF HEALTH AND D74, Atlanta, Georgia 30329. the proposed collection of information
HUMAN SERVICES Instructions: All submissions received is necessary for the proper performance
must include the agency name and of the functions of the agency, including
Centers for Disease Control and Docket Number. All relevant comments whether the information shall have
Prevention received will be posted without change practical utility; (b) the accuracy of the
to Regulations.gov, including any agency’s estimate of the burden of the
[60 Day–16–15BHH; Docket No. CDC–2016– personal information provided. For proposed collection of information; (c)
0087] access to the docket to read background ways to enhance the quality, utility, and
documents or comments received, go to clarity of the information to be
Proposed Data Collection Submitted
Regulations.gov. collected; (d) ways to minimize the
for Public Comment and
Please note: All public comment should be burden of the collection of information
Recommendations
submitted through the Federal eRulemaking on respondents, including through the
AGENCY: Centers for Disease Control and portal (Regulations.gov) or by U.S. mail to the use of automated collection techniques
Prevention (CDC), Department of Health address listed above. or other forms of information
and Human Services (HHS). FOR FURTHER INFORMATION CONTACT: To technology; and (e) estimates of capital
ACTION: Notice with comment period. request more information on the or start-up costs and costs of operation,
proposed project or to obtain a copy of maintenance, and purchase of services
SUMMARY: The Centers for Disease the information collection plan and to provide information. Burden means
Control and Prevention (CDC), as part of instruments, contact the Information the total time, effort, or financial
its continuing efforts to reduce public Collection Review Office, Centers for resources expended by persons to
burden and maximize the utility of Disease Control and Prevention, 1600 generate, maintain, retain, disclose or
government information, invites the Clifton Road, NE., MS–D74, Atlanta, provide information to or for a Federal
general public and other Federal Georgia 30329; phone: 404–639–7570; agency. This includes the time needed
agencies to take this opportunity to Email: omb@cdc.gov. to review instructions; to develop,
comment on proposed and/or acquire, install and utilize technology
SUPPLEMENTARY INFORMATION: Under the
continuing information collections, as and systems for the purpose of
Paperwork Reduction Act of 1995 (PRA)
required by the Paperwork Reduction collecting, validating and verifying
(44 U.S.C. 3501–3520), Federal agencies
Act of 1995. This notice invites information, processing and
must obtain approval from the Office of
comment on the Personal Protective maintaining information, and disclosing
mstockstill on DSK4VPTVN1PROD with NOTICES
Management and Budget (OMB) for each
Equipment Information (PPE-Info) and providing information; to train
collection of information they conduct
Database which is a compendium of personnel and to be able to respond to
or sponsor. In addition, the PRA also
personal protective equipment (PPE) a collection of information, to search
requires Federal agencies to provide a
Federal regulations and consensus data sources, to complete and review
60-day notice in the Federal Register
standards. the collection of information; and to
concerning each proposed collection of
DATES: Written comments must be information, including each new transmit or otherwise disclose the
received on December 7, 2015. proposed collection, each proposed information.
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![60908 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
Leroy A. Richardson, FOR FURTHER INFORMATION CONTACT: To Proposed Project
Chief, Information Collection Review Office, request more information on the The National Ambulatory Medical
Office of Scientific Integrity, Office of the proposed project or to obtain a copy of
Associate Director for Science, Office of the
Care Survey (NAMCS), (OMB No. 0920–
the information collection plan and 0234, expires 12/31/2017)—Revision —
Director, Centers for Disease Control and instruments, contact the Information
Prevention. National Center for Health Statistics
Collection Review Office, Centers for (NCHS), Centers for Disease Control and
[FR Doc. 2015–25646 Filed 10–7–15; 8:45 am]
Disease Control and Prevention, 1600 Prevention (CDC).
BILLING CODE 4163–18–P Clifton Road, NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570; Background and Brief Description
Email: omb@cdc.gov. Section 306 of the Public Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Under the Service (PHS) Act (42 U.S.C. 242k), as
Paperwork Reduction Act of 1995 (PRA) amended, authorizes that the Secretary
Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies of Health and Human Services, acting
Prevention must obtain approval from the Office of through NCHS, shall collect statistics on
Management and Budget (OMB) for each the utilization of health care provided
[60Day–16–0234; Docket No. CDC–2015– collection of information they conduct by non-federal office-based physicians
0086] or sponsor. In addition, the PRA also in the United States. On December 19,
requires Federal agencies to provide a 2014, the OMB approved data collection
Proposed Data Collection Submitted for three years from 2015 to 2017. This
for Public Comment and 60-day notice in the Federal Register
concerning each proposed collection of revision is to request approval to
Recommendations continue NAMCS data collection
information, including each new
AGENCY: Centers for Disease Control and activities for three years from 2016–
proposed collection, each proposed
Prevention (CDC), Department of Health 2018 and to add questions to the
extension of existing collection of
and Human Services (HHS). physician interview that pertain to
information, and each reinstatement of
policies, services, and experiences
ACTION: Notice with comment period. previously approved information
related to the prevention and treatment
collection before submitting the
SUMMARY: The Centers for Disease of sexually transmitted infections (STIs)
collection to OMB for approval. To
Control and Prevention (CDC), as part of and HIV prevention among adolescents
comply with this requirement, we are
its continuing efforts to reduce public and others. Small modifications will
publishing this notice of a proposed
burden and maximize the utility of also be made to questions on the use of
data collection as described below.
government information, invites the electronic health records. This notice
Comments are invited on: (a) Whether also covers a decrease in the sample size
general public and other Federal
the proposed collection of information resulting from smaller budget
agencies to take this opportunity to
is necessary for the proper performance allocations. Due to this decrease,
comment on proposed and/or
of the functions of the agency, including selected state estimates will not be
continuing information collections, as
required by the Paperwork Reduction whether the information shall have available for 2016–2018 data.
Act of 1995. This notice invites practical utility; (b) the accuracy of the The National Ambulatory Medical
comment on the proposed revision of agency’s estimate of the burden of the Care Survey (NAMCS) has been
the National Ambulatory Medical Care proposed collection of information; (c) conducted intermittently from 1973
Survey (NAMCS). The purpose of ways to enhance the quality, utility, and through 1985, and annually since 1989.
NAMCS is to meet the needs and clarity of the information to be The purpose of NAMCS, a voluntary
demands for statistical information collected; (d) ways to minimize the survey, is to meet the needs and
about the provision of ambulatory burden of the collection of information demands for statistical information
medical care services in the United on respondents, including through the about the provision of ambulatory
States. use of automated collection techniques medical care services in the United
or other forms of information States. Ambulatory services are
DATES: Written comments must be technology; and (e) estimates of capital rendered in a wide variety of settings,
received on or before December 7, 2015. or start-up costs and costs of operation, including physicians’ offices and
ADDRESSES: You may submit comments, maintenance, and purchase of services hospital outpatient and emergency
identified by Docket No. CDC–2016– to provide information. Burden means departments.
0026 by any of the following methods: the total time, effort, or financial The NAMCS target universe consists
• Federal eRulemaking Portal: resources expended by persons to of all office visits made by ambulatory
Regulation.gov. Follow the instructions generate, maintain, retain, disclose or patients to non-Federal office-based
for submitting comments. provide information to or for a Federal physicians (excluding those in the
• Mail: Leroy A. Richardson, agency. This includes the time needed specialties of anesthesiology, radiology,
Information Collection Review Office, to review instructions; to develop, and pathology) who are engaged in
Centers for Disease Control and acquire, install and utilize technology direct patient care. In 2006, physicians
Prevention, 1600 Clifton Road NE., MS– and systems for the purpose of and mid-level providers (i.e., nurse
D74, Atlanta, Georgia 30329. collecting, validating and verifying practitioners, physician assistants, and
Instructions: All submissions received information, processing and nurse midwives) practicing in
mstockstill on DSK4VPTVN1PROD with NOTICES
must include the agency name and maintaining information, and disclosing community health centers (CHCs) were
Docket Number. All relevant comments and providing information; to train added to the NAMCS sample, and these
received will be posted without change personnel and to be able to respond to data will continue to be collected.
to Regulations.gov, including any a collection of information, to search To complement NAMCS data, NCHS
personal information provided. For data sources, to complete and review initiated the National Hospital
access to the docket to read background the collection of information; and to Ambulatory Medical Care Survey
documents or comments received, go to transmit or otherwise disclose the (NHAMCS, OMB No. 0920–0278,
Regulations.gov. information. expires 02/28/18) in 1992 to provide
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Document Created: 2015-12-15 08:43:04
Document Modified: 2015-12-15 08:43:04
| 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 December 7, 2015. | |
| 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 | 80 FR 60906 |
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