82 FR 39788 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 161 (August 22, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 161 (August 22, 2017)
| Page Range | 39788-39790 | |
| FR Document | 2017-17699 |
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)] [Notices] [Pages 39788-39790] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17699] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-0740; Docket No. CDC-2017-0060] 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 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 Medical Monitoring Project, which collects interview and medical record data on a probability sample of HIV-diagnosed persons in order to provide national estimates of access to and utilization of HIV-related medical care and services, the quality of HIV-related ambulatory care, and HIV- related behaviors and clinical outcomes. DATES: Written comments must be received on or before October 23, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0060 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 Leroy Richardson, 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 [[Page 39789]] 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 Medical Monitoring Project (MMP)--(OMB Control Number 0920-0740 Expiration 6/30/2018)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention (DHAP) requests a revision of the currently approved Information Collection Request: ``Medical Monitoring Project'' expiring June 30, 2018. This data collection addresses the need for national estimates of access to and utilization of HIV-related medical care and services, the quality of HIV-related ambulatory care, and HIV- related behaviors and clinical outcomes. For the proposed project, the same data collection methods will be used as for the currently approved project. Data would be collected from a probability sample of HIV-diagnosed adults in the U.S. who consent to an interview and abstraction of their medical records. As for the currently approved project, de-identified information would also be extracted from HIV case surveillance records for a dataset, referred to as the minimum dataset, which is used to assess non- response bias, for quality control, to improve the ability of MMP to monitor ongoing care and treatment of HIV-infected persons, and to make inferences from the MMP sample to HIV-diagnosed persons nationally. No other Federal agency collects such nationally representative population-based information from HIV-diagnosed adults. The data are expected to have significant implications for policy, program development, and resource allocation at the state/local and national levels. The changes proposed in this request update the data collection system to meet prevailing information needs and enhance the value of MMP data, while remaining within the scope of the currently approved project purpose. The result is a 11% reduction in burden, or a reduction of 786 total burden hours annually. Specifically, the removal of three unfunded project areas reduces the number of interviews conducted and the number of persons for whom healthcare facility staff will be asked for contact information, assistance with approaching for participation, and pulling medical records. Changes were made that did not affect the burden, listed below: Sampled persons found to have resided in a non-funded project area on the date of sampling will be considered ineligible for the project, because non-funded project areas were deemed ineligible in the first stage of sampling. Tracking data reports will no longer be sent to CDC, as this information is no longer needed. The average token of appreciation for participants has been increased from $25 to $50. Changes have been made to the respondent consent form to decrease the reading comprehension level and clarify whom participants should contact for different concerns. Forty-two data elements were removed from the minimum data set and forty data elements were added. Because these data elements are extracted from the HIV surveillance system from which they are sampled, these changes do not affect the burden of the project. This proposed data collection would supplement the National HIV Surveillance System (NHSS, OMB Control No. 0920-0573, Exp. 6/30/2019) in 23 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS. The participation of respondents is voluntary. There is no cost to the respondents other than their time. Through their participation, respondents will help to improve programs to prevent HIV infection as well as services for those who already have HIV. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Total response Type of respondent Form name Number of responses per Average hours burden respondents respondent per response (hours) ---------------------------------------------------------------------------------------------------------------- Sampled, Eligible HIV-Infected Interview 7,760 1 45/60 5,820 Persons. Questionnaire. Facility office staff looking N/A............. 1,940 1 2/60 65 up contact information. Facility office staff N/A............. 970 1 5/60 81 approaching sampled persons for enrollment. Facility office staff pulling N/A............. 7,760 1 3/60 388 medical records. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 6,354 ---------------------------------------------------------------------------------------------------------------- [[Page 39790]] 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. 2017-17699 Filed 8-21-17; 8:45 am] BILLING CODE 4163-18-P
![39788 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
surveillance system of such events. The Potential respondents are any of the LTBI treatment adverse events statistics
objective of the project is to determine 60 reporting areas for the national TB and will conduct special analyses for
the annual number and temporal trends surveillance system (the 50 states, the publication in peer-reviewed scientific
of SAEs associated with any treatment District of Columbia, New York City, journals to further describe and
for LTBI in the United States. Puerto Rico, and 7 jurisdictions in the interpret these data.
Surveillance of such events will provide Pacific and Caribbean). The Food and Drug Administration
data to support periodic evaluation or CDC will collect data using the data
(FDA) collects data on adverse events
potential revision of guidelines for collection form for SAEs associated with
related to drugs through the FDA
treatment of persons with LTBI. LTBI treatment. Based on previous
MedWatch Program. CDC is encouraging
The CDC seeks to request OMB reporting, CDC anticipates receiving an
approval for a three-year extension of average of six responses per year from health departments and healthcare
the previously approved National the 60 reporting areas. The data providers to report SAEs to FDA.
Surveillance for Severe Adverse Events collection form is completed by Reporting will be conducted through
Associated with Treatment of Latent healthcare providers and health telephone, email, or during CDC site
Tuberculosis Infection—(OMB No. departments for each reported visits.
0920–0773, expires January 17, 2018). hospitalization or death related to In this request, CDC is requesting
This project will continue the passive treatment of LTBI and contains approval for approximately 36 burden
reporting system for SAEs associated demographic, clinical, and laboratory hours annually. The only cost to
with therapy for LTBI. The system will information. respondents is time to gather medical
rely on medical chart review and/or CDC will analyze and periodically records and time to complete the
onsite investigations by TB control staff. publish reports summarizing national reporting form.
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)
Physician ........................................... NSSAE ............................................. 6 1 1 6
Nurse ................................................. NSSAE ............................................. 6 1 4 24
Medical Clerk .................................... NSSAE ............................................. 6 1 1 6
Total ........................................... ........................................................... ........................ ........................ ........................ 36
Leroy A. Richardson, continuing information collections, as Please note: All public comment
Chief, Information Collection Review Office, required by the Paperwork Reduction should be submitted through the
Office of Scientific Integrity, Office of the Act of 1995. This notice invites Federal eRulemaking portal
Associate Director for Science, Office of the comment on the Medical Monitoring (regulations.gov) or by U.S. mail to the
Director, Centers for Disease Control and Project, which collects interview and address listed above.
Prevention. medical record data on a probability
[FR Doc. 2017–17708 Filed 8–21–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: To
sample of HIV-diagnosed persons in
request more information on the
BILLING CODE 4163–18–P order to provide national estimates of
proposed project or to obtain a copy of
access to and utilization of HIV-related
the information collection plan and
medical care and services, the quality of
DEPARTMENT OF HEALTH AND instruments, contact Leroy Richardson,
HIV-related ambulatory care, and HIV-
HUMAN SERVICES Information Collection Review Office,
related behaviors and clinical outcomes.
Centers for Disease Control and
DATES: Written comments must be
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–
Prevention received on or before October 23, 2017. D74, Atlanta, Georgia 30329; phone:
ADDRESSES: You may submit comments, 404–639–7570; Email: omb@cdc.gov.
[60Day–17–0740; Docket No. CDC–2017– identified by Docket No. CDC–2017–
0060] 0060 by any of the following methods: SUPPLEMENTARY INFORMATION: Under the
• Federal eRulemaking Portal: Paperwork Reduction Act of 1995 (PRA)
Proposed Data Collection Submitted (44 U.S.C. 3501–3520), Federal agencies
Regulations.gov. Follow the instructions
for Public Comment and must obtain approval from the Office of
for submitting comments.
Recommendations • Mail: Leroy A. Richardson, Management and Budget (OMB) for each
AGENCY: Centers for Disease Control and Information Collection Review Office, collection of information they conduct
Prevention (CDC), Department of Health Centers for Disease Control and or sponsor. In addition, the PRA also
and Human Services (HHS). Prevention, 1600 Clifton Road NE., MS– requires Federal agencies to provide a
ACTION: Notice with comment period. D74, Atlanta, Georgia 30329. 60-day notice in the Federal Register
Instructions: All submissions received concerning each proposed collection of
SUMMARY: The Centers for Disease must include the agency name and information, including each new
sradovich on DSK3GMQ082PROD with NOTICES
Control and Prevention (CDC), as part of Docket Number. All relevant comments proposed collection, each proposed
its continuing effort to reduce public received will be posted without change extension of existing collection of
burden and maximize the utility of to Regulations.gov, including any information, and each reinstatement of
government information, invites the personal information provided. For previously approved information
general public and other Federal access to the docket to read background collection before submitting the
agencies to take this opportunity to documents or comments received, go to collection to OMB for approval. To
comment on proposed and/or Regulations.gov. comply with this requirement, we are
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![39790 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
Leroy A. Richardson, applying for LIHEAP block grant funds OCS seeks renewal of this form
Chief, Information Collection Review Office, must, prior to receiving federal funds, without any changes. A sample model
Office of Scientific Integrity, Office of the submit an annual application (Model plan showing these proposed changes
Associate Director for Science, Office of the Plan, ACF–122) that meets the LIHEAP can be found on the U.S. Department of
Director, Centers for Disease Control and statutory and regulatory requirements. Health and Human Services, ACF/OCS
Prevention. In addition to the Model Plan, grantees LIHEAP Program Resources page at:
[FR Doc. 2017–17699 Filed 8–21–17; 8:45 am] are also required to complete the https://www.acf.hhs.gov/ocs/resource/
BILLING CODE 4163–18–P Mandatory Grant Application SF–424– funding-applications.
Mandatory, which is the first section of On April 3, 2017, ACF published a
the Model Plan. Federal Register Notice seeking 60 days
DEPARTMENT OF HEALTH AND The LIHEAP Model Plan is an of public comment on this proposed
HUMAN SERVICES electronic form and is submitted to the information collection. One state
Administration for Children and Administration for Children and grantee provided comments. ACF
Families Families (ACF), Office of Community revised the Plan to address the
Services (OCS) through the On-line Data comments by ensuring that open field
Submission for OMB Review; Collection (OLDC) system within boxes and attachment capability are
Comment Request GrantSolutions, which is currently available if the answer choices are
being used by all LIHEAP grantees to insufficient to address the questions.
Title: Application Requirements for submit other required LIHEAP reporting The revised model plan can be
the Low Income Home Energy forms. In order to reduce the reporting viewed on the OCS Web site at: http://
Assistance Program (LIHEAP) Plan. burden, all data entries from each www.acf.hhs.gov/programs/ocs/
OMB No.: 0970–0075. grantee’s prior year’s submission of the programs/liheap.
Description: States, including the Model Plan in OLDC is saved and re- Respondents: State, the District of
District of Columbia, tribes, tribal populated (cloned) into the form for the Columbia, U.S. Territories and Tribal
organizations, and U.S. territories following fiscal year’s application. governments.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
LIHEAP Detailed Model Plan .......................................................................... 210 1 0.50 105
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND number is 301–468–1100. Answers to
Hours (all respondents): 105. HUMAN SERVICES commonly asked questions including
Additional Information: Copies of the information regarding special
proposed collection may be obtained by Food and Drug Administration accommodations due to a disability,
writing to the Administration for [Docket No. FDA–2017–N–4885] visitor parking, and transportation may
Children and Families, Office of be accessed at http://www3.hilton.com/
Planning, Research and Evaluation, 330 Pediatric Advisory Committee; Notice en/hotels/maryland/hilton-washington-
C Street SW., Washington, DC 20201. of Meeting; Establishment of a Public dc-rockville-hotel-and-executive-
Attention Reports Clearance Officer. All Docket; Request for Comments meeting-ctr-IADMRHF/index.html.
FDA is establishing a docket for
requests should be identified by the title AGENCY: Food and Drug Administration, public comment on this document. The
of the information collection. Email HHS. docket number is FDA–2017–N–4885.
address: infocollection@acf.hhs.gov. ACTION: Notice; establishment of a The docket will close on September 13,
OMB Comment: OMB is required to public docket; request for comments. 2017. Submit either electronic or
make a decision concerning the written comments on this public
collection of information between 30 SUMMARY: The Food and Drug meeting by that date. Late, untimely
and 60 days after publication of this Administration (FDA or the Agency) comments will not be considered.
document in the Federal Register. announces a forthcoming public Electronic comments must be submitted
Therefore, a comment is best assured of advisory committee meeting of the on or before September 13, 2017. The
having its full effect if OMB receives it Pediatric Advisory Committee (PAC). https://www.regulations.gov electronic
within 30 days of publication. Written The general function of the committee is filing system will accept comments
comments and recommendations for the to provide advice and recommendations until midnight Eastern Time at the end
proposed information collection should to the Agency on FDA’s regulatory of September 13, 2017. Comments
be sent directly to the following: Office issues. The meeting will be open to the received by mail/hand delivery/courier
of Management and Budget, Paperwork public. FDA is establishing a docket for (for written/paper submissions) will be
Reduction Project, Email: OIRA_ public comments. considered timely if they are
SUBMISSION@OMB.EOP.GOV, Attn: DATES: The meeting will be held on
sradovich on DSK3GMQ082PROD with NOTICES
postmarked or the delivery service
Desk Officer for the Administration for September 11, 2017, from 8:30 a.m. to acceptance receipt is on or before that
Children and Families. 5:30 p.m. and September 12, 2017, from date.
8:30 a.m. to 1 p.m. Comments received on or before
Robert Sargis,
ADDRESSES: Hilton Washington DC/ August 28, 2017, will be provided to the
Reports Clearance Officer. Rockville Hotel & Executive Meeting committee. Comments received after
[FR Doc. 2017–17681 Filed 8–21–17; 8:45 am] Center, 1750 Rockville Pike, Rockville, that date will be taken into
BILLING CODE 4184–01–P MD 20852. The hotel’s telephone consideration by FDA.
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Document Created: 2018-10-24 11:55:25
Document Modified: 2018-10-24 11:55:25
| 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 October 23, 2017. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy Richardson, 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 | 82 FR 39788 |
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