81 FR 26795 - 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 86 (May 4, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 86 (May 4, 2016)
| Page Range | 26795-26797 | |
| FR Document | 2016-10399 |
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)] [Notices] [Pages 26795-26797] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10399] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16AHI; Docket No. CDC-2016-0041] 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 a proposed information collection project entitled ``Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients''. DATES: Written comments must be received on or before July 5, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0041 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 [[Page 26796]] 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 ``Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients''--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Community-Based Organizations (CBOs) play an essential role in reaching persons at high risk of transmitting and acquiring HIV infection. Through Cooperative Agreement #CDC-RFA-PS15-1502 (CBO-HPS), CDC funds 90 CBOs to provide comprehensive HIV prevention services to HIV-positive persons and high-risk HIV-negative persons. However, the CBO-HIV Prevention Services (HPS) awardees are not required to monitor or report on critical outcomes such as whether HIV-positive persons who are linked to HIV medical care were retained in care or prescribed ART, and whether high-risk HIV-negative persons who were referred to Pre- Exposure Prophylaxis (PrEP) initiated its use. Also, CBO-HPS CBOs are not required to collect and report data about clients' perceived barriers to accessing HIV prevention services. CBO-OMP will fund a subset of CBO-HPS awardees to collect and report data to CDC about the utilization and outcomes of the HIV prevention and support services. This will increase understanding of HIV prevention and support services received by CBO-HPS clients, the outcomes of these services, and successes and challenges related to service provision and utilization. The respondent universe will comprise clients at 15-18 CBOs funded by CBO-HPS. CBO-OPM is organized in two categories: Category 1--HIV- positive clients and Category 2--high-risk HIV-negative clients. This information collection will evaluate HIV-prevention services over time through participant interviews, record/chart review, CBO-HPS staff interviews, and focus groups. Participant interviews will include questions for participants living with HIV-positive and high-risk HIV- negative clients at CBOs funded by CBO-HPS about demographics, HIV- related risk behaviors, HIV prevention and support services received, service outcomes, and experiences with services over time; staff interviews about strategies for and barriers to recruiting and engaging clients in HIV prevention and support services; and focus groups with clients who are receiving HIV prevention services at CBOs. For Category 1, self-reported client interview data will be collected at baseline, 3, 6, 9 and 15 months. For Category 2, self- reported client level data will be collected at baseline, 3, 6, and 9 months. Participants will complete a 30-minute, staff-facilitated interview at baseline and 20-minute staff-facilitated interviews at each follow-up, to assess the outcomes of HIV-prevention services they receive. This project will also collect information from CBO-HPS Staff. Two CBO-HPS staff interviews will be conducted for Category 1 and two staff interviews will be conducted for Category 2. All interviews are expected to last 2.5 hours. This project will also collect information from participant focus groups. Respondents will also complete a short demographic questionnaire. Focus groups will occur twice during the project period and will last approximately 90 minutes. All electronic data will be password protected and accessible only to project staff and direct supervisors. Data will be stored on network drives which are regularly backed up by staff. Participation in this project is strictly voluntary. The consent process will be implemented according to the local/state policies of the funded agencies. Consent forms are provided. The consent process for CBO-OMP involves the agency staff providing an overview of the project that includes a description of the benefits of as well as the risks and discomforts to participation as well as the protections for the respondent's privacy. Participants must sign the consent form prior to enrolling into the project. The information collected by each funded agency may include personally identifiable information, such as name and contact information, in order to provide continuity of service, follow-up of referrals, schedule follow-up interviews and other outreach activities. Personally identifiable information will be kept in a locked file cabinet and will be accessible only to appropriate agency staff. Any individually identifiable information collected by funded agencies will not be submitted to CDC. The category 1 information collection will occur over 33 months and will involve up to 15 CBOs. The population targeted by Category 1 are HIV-positive clients who are receiving CBO-HPS services and have been provided a CBO-HPS referral to HIV medical care. They will be screened, interviewed and CBO staff will collect their medical records related to their HIV-medical care visits, CD4 count and viral loads, and prescription to ART. The Category 2 information collection will occur over 21 months and involve up to 3 CBOs who will target high-risk HIV-negative clients who are receiving CBO-HPS services. CBOs will screen 225 persons each year. CBO staff will collect their medical records about medical care visits, PrEP prescriptions and information about which CBO-HPS referrals. Participants will be administered a baseline interview as well as interviews at 3 months, 6 months, and 9 months. Each CBO will also conduct two focus groups over the project period, one in each year of the evaluation. Each of the CBOs funded to participate in this project will be required to submit data they've collected each month to CDC, including the screener, medical records and CBO-HPS referrals, baseline interview, 3-month follow-up interview, 6-month follow-up interview, 9- month follow-up interview, focus groups, and staff interviews, respectively. There is no cost to respondents other than their time. Total burden hours are 1,125. [[Page 26797]] Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per response Total burden respondents respondent (hours) (hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- General public................................. Screener Participant Interview Category 175 1 3/60 9 1. Facility office staff.......................... Medical records abstraction Category 1. 120 3 3/60 18 CBO-HPS grantees............................... CBO-HPS Referrals Category 1........... 120 3 3/60 18 General public................................. Baseline Interview Category 1.......... 150 1 40/60 100 General public................................. 3,6,9, and 15 Month Follow-up Interview 120 4 30/60 240 Category 1. General public................................. Screener Focus Group Category 1........ 150 1 3/60 8 General Public................................. Focus Group Questionnaire Category 1... 90 1 2/60 3 General public................................. Focus Group Category 1................. 90 1 1.5 135 CBO-HPS grantees............................... Staff Interview Category 1............. 30 1 2.5 75 CBO-OMP CBOs................................... Data submission Category 1 and 2....... 18 12 10/60 36 General public................................. Screener Participant Interview Category 225 1 3/60 12 2. Facility office staff.......................... Medical records abstraction Category 2. 168 2 3/60 17 CBO-HPS grantees............................... CBO-HPS Referrals Category 2........... 168 2 3/60 17 General public................................. Baseline Interview Category 2.......... 210 1 40/60 140 General public................................. 3,6, and 9 Month Follow-up Interview 168 3 30/60 252 Category 2. General Public................................. Screener Focus group Category 2........ 30 1 3/60 2 General Public................................. Focus Group Questionnaire Category 2... 18 1 2/60 1 General public................................. Focus Group Category 2................. 18 1 1.5 27 CBO-HPS grantees............................... Staff Interview Category 2............. 6 1 2.5 15 --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 1,125 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. 2016-10399 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices 26795
nominations for membership on the D At least one letter of SUMMARY: The Centers for Disease
BCCEDCAC. The committee provides recommendation from a person(s) not Control and Prevention (CDC), as part of
advice and guidance to the Secretary, employed by the U.S. Department of its continuing efforts to reduce public
HHS, and the Director, CDC, regarding Health and Human Services. Candidates burden and maximize the utility of
the early detection and control of breast may submit letter(s) from current HHS government information, invites the
and cervical cancer. The committee employees if they wish, but at least one general public and other Federal
makes recommendations regarding letter must be submitted by a person not agencies to take this opportunity to
national program goals and objectives; employed by HHS. comment on proposed and/or
implementation strategies; program Nominations should be submitted continuing information collections, as
priorities, including surveillance, (postmarked or received) by June 24, required by the Paperwork Reduction
epidemiologic investigations, education 2016: Act of 1995. This notice invites
and training, information dissemination, D Electronic submissions: You may comment on a proposed information
professional interactions and submit nominations, including collection project entitled ‘‘Community-
collaborations, and policy. attachments, electronically to Based Organization Outcome
Nominations are being sought for bccedcac@cdc.gov. Monitoring Projects for CBO HIV
individuals who have expertise and D Regular, Express or Overnight Mail: Prevention Services Clients’’.
qualifications necessary to contribute to Written nominations may be submitted DATES: Written comments must be
the accomplishments of the committee’s to the following addressee only: Ms. received on or before July 5, 2016.
objectives. The Secretary, HHS, acting Jameka Reese Blackmon, MBA, CMP ADDRESSES: You may submit comments,
through the Director, CDC, shall appoint c/o BCCEDCAC Secretariat, Centers for identified by Docket No. CDC–2016–
to the advisory committee nominees Disease Control and Prevention, 3719 0041 by any of the following methods:
with expertise in breast cancer, cervical North Peachtree Road, Building 100, • Federal eRulemaking Portal:
cancer, medicine, public health, Chamblee, Georgia 30341. Regulation.gov. Follow the instructions
behavioral science, epidemiology, Telephone and facsimile submissions for submitting comments.
radiology, pathology, clinical medical cannot be accepted. • Mail: Leroy A. Richardson,
care, health education, and surveillance. Contact Person for More Information: Information Collection Review Office,
Two members may be representatives of Jameka R. Blackmon, MBA, CMP, Centers for Disease Control and
the general public with personal Designated Federal Officer, National Prevention, 1600 Clifton Road NE., MS–
experience in issues related to breast or Center for Chronic Disease Prevention D74, Atlanta, Georgia 30329.
cervical cancer early detection and and Health Promotion, CDC, 4770 Instructions: All submissions received
control. Members may be invited to Buford Hwy. NE., Mailstop F76, Atlanta, must include the agency name and
serve for up to four years. Georgia 30341, Telephone (770) 488– Docket Number. All relevant comments
The next cycle of selection of 4880; Fax (770) 488–4760; Email: received will be posted without change
candidates will conclude in the Summer bccedcac@cdc.gov. to Regulations.gov, including any
of 2016, for selection of potential The Director, Management Analysis personal information provided. For
nominees to replace members whose and Services Office, has been delegated access to the docket to read background
terms will end on March 31, 2017. the authority to sign Federal Register documents or comments received, go to
Selection of members is based on notices pertaining to announcements of Regulations.gov.
candidates’ qualifications to contribute meetings and other committee
management activities, for both the Please note: All public comment should be
to the accomplishment of BCCEDCAC
Centers for Disease Control and the submitted through the Federal eRulemaking
objectives. The U.S. Department of portal (Regulations.gov) or by U.S. mail to the
Health and Human Services will give Agency for Toxic Substances and address listed above.
close attention to equitable geographic Disease Registry.
distribution and to minority and female FOR FURTHER INFORMATION CONTACT: To
Catherine Ramadei,
representation so long as the request more information on the
Acting Director, Management Analysis and proposed project or to obtain a copy of
effectiveness of the Committee is not Services Office, Centers for Disease Control
impaired. Appointments shall be made and Prevention.
the information collection plan and
without discrimination on the basis of instruments, contact the Information
[FR Doc. 2016–10421 Filed 5–3–16; 8:45 am]
age, race, ethnicity, gender, sexual Collection Review Office, Centers for
BILLING CODE 4163–18–P
orientation, HIV status, disability, and Disease Control and Prevention, 1600
cultural, religious, or socioeconomic Clifton Road NE., MS–D74, Atlanta,
status. Consideration is given to a broad DEPARTMENT OF HEALTH AND Georgia 30329; phone: 404–639–7570;
representation of geographic areas HUMAN SERVICES Email: omb@cdc.gov.
within the U.S., with diverse SUPPLEMENTARY INFORMATION: Under the
representation of both genders, ethnic Centers for Disease Control and Paperwork Reduction Act of 1995 (PRA)
and racial minorities, and persons with Prevention (44 U.S.C. 3501–3520), Federal agencies
disabilities. Nominees must be U.S. must obtain approval from the Office of
citizens, and cannot be full-time [60Day–16–16AHI; Docket No. CDC–2016– Management and Budget (OMB) for each
employees of the U.S. Government. 0041] collection of information they conduct
Candidates should submit the or sponsor. In addition, the PRA also
asabaliauskas on DSK3SPTVN1PROD with NOTICES
following items: Proposed Data Collection Submitted requires Federal agencies to provide a
D Current curriculum vitae or resume, for Public Comment and 60-day notice in the Federal Register
including complete contact information Recommendations concerning each proposed collection of
(name, affiliation, mailing address, AGENCY: Centers for Disease Control and information, including each new
telephone numbers, fax number, email Prevention (CDC), Department of Health proposed collection, each proposed
address); and Human Services (HHS). extension of existing collection of
D A 150 word biography for the information, and each reinstatement of
ACTION: Notice with comment period.
nominee; previously approved information
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![Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices 26797
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden Total burden
Type of respondent Form name responses per
respondents response (hours)
respondent (hours)
General public ................................... Screener Participant Interview Cat- 175 1 3/60 9
egory 1.
Facility office staff .............................. Medical records abstraction Cat- 120 3 3/60 18
egory 1.
CBO–HPS grantees .......................... CBO–HPS Referrals Category 1 ..... 120 3 3/60 18
General public ................................... Baseline Interview Category 1 ......... 150 1 40/60 100
General public ................................... 3,6,9, and 15 Month Follow-up 120 4 30/60 240
Interview Category 1.
General public ................................... Screener Focus Group Category 1 150 1 3/60 8
General Public ................................... Focus Group Questionnaire Cat- 90 1 2/60 3
egory 1.
General public ................................... Focus Group Category 1 ................. 90 1 1.5 135
CBO–HPS grantees .......................... Staff Interview Category 1 ............... 30 1 2.5 75
CBO–OMP CBOs .............................. Data submission Category 1 and 2 18 12 10/60 36
General public ................................... Screener Participant Interview Cat- 225 1 3/60 12
egory 2.
Facility office staff .............................. Medical records abstraction Cat- 168 2 3/60 17
egory 2.
CBO–HPS grantees .......................... CBO–HPS Referrals Category 2 ..... 168 2 3/60 17
General public ................................... Baseline Interview Category 2 ......... 210 1 40/60 140
General public ................................... 3,6, and 9 Month Follow-up Inter- 168 3 30/60 252
view Category 2.
General Public ................................... Screener Focus group Category 2 .. 30 1 3/60 2
General Public ................................... Focus Group Questionnaire Cat- 18 1 2/60 1
egory 2.
General public ................................... Focus Group Category 2 ................. 18 1 1.5 27
CBO–HPS grantees .......................... Staff Interview Category 2 ............... 6 1 2.5 15
Total ........................................... .......................................................... ........................ ........................ ........................ 1,125
Leroy A. Richardson, Infectious Diseases (NCEZID), CDC; and replace members whose terms will end
Chief, Information Collection Review Office, the Director, Division of Healthcare on June 30, 2017.
Office of Scientific Integrity, Office of the Quality Promotion (DHQP), NCEZID, Selection of members is based on
Associate Director for Science, Office of the CDC, regarding the practice of infection candidates’ qualifications to contribute
Director, Centers for Disease Control and control and strategies for surveillance, to the accomplishment of HICPAC’s
Prevention. prevention, and control of healthcare- objectives (http://www.cdc.gov/hicpac/
[FR Doc. 2016–10399 Filed 5–3–16; 8:45 am] associated infections, antimicrobial about.html). The U.S. Department of
BILLING CODE 4163–18–P resistance, and related events in settings Health and Human Services will give
where healthcare is provided, including close attention to equitable geographic
hospitals, outpatient settings, long-term- distribution and to minority and female
DEPARTMENT OF HEALTH AND care facilities, and home health representation so long as the
HUMAN SERVICES agencies. effectiveness of the Committee is not
Nominations are being sought for impaired.
Centers for Disease Control and individuals who have expertise and Appointments shall be made without
Prevention qualifications necessary to contribute to discrimination on the basis of age, race,
the accomplishment of HICPAC ethnicity, gender, sexual orientation,
Request for Nominations of
objectives. HIV status, disability, and cultural,
Candidates To Serve on the Healthcare
The Secretary, HHS, acting through religious, or socioeconomic status.
Infection Control Practices Advisory
the Director, CDC, shall appoint to the Consideration is given to a broad
Committee (HICPAC)
advisory committee nominees with representation of geographic areas
The Centers for Disease Control and expertise to provide advice regarding within the U.S., with diverse
Prevention (CDC) is soliciting the practice of healthcare infection representation of both genders, ethnic
nominations for possible membership control, strategies for surveillance and and racial minorities, and persons with
on the Healthcare Infection Control prevention and control of healthcare- disabilities. Nominees must be U.S.
Practices Advisory Committee associated infections in United States citizens, and cannot be full-time
(HICPAC). healthcare facilities. Consideration is employees of the U.S. Government.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The Committee provides advice and given to professional training and Candidates should submit the following
guidance to the Secretary, Department background, points of view represented, items:
of Health and Human Services (HHS); and upcoming issues to be addressed by Current curriculum vitae or resume,
the Director, Centers for Disease Control the committee. Nominees may be including complete contact information
and Prevention (CDC); the Deputy invited to serve for four-year terms. The (name, affiliation, mailing address,
Director, Office of Infectious Diseases next cycle of selection of candidates telephone numbers, fax number, email
(OID), CDC; the Director, National will begin in the spring of 2016, for address) ; At least one letter of
Center for Emerging and Zoonotic selection of potential nominees to recommendation stating the
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Document Created: 2016-05-04 01:23:22
Document Modified: 2016-05-04 01:23:22
| 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 July 5, 2016. | |
| 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 26795 |
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