81 FR 15725 - 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 57 (March 24, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 57 (March 24, 2016)
| Page Range | 15725-15727 | |
| FR Document | 2016-06707 |
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)] [Notices] [Pages 15725-15727] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06707] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16VB; Docket No. CDC-2016-0032] 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 request entitled ``HIV Knowledge, Beliefs, Attitudes, and Practices of Providers in the Southeast (K-BAP Study)''. CDC is requesting a three-year approval for new data collection to identify areas of HIV prevention knowledge and practice strengths and deficits among primary care providers, in order to target limited HIV prevention resources to achieve the greatest reduction in new HIV infections and optimize HIV clinical care in clinical settings. The target population will be primary care providers practicing in high- prevalence metropolitan statistical geographic areas with large at-risk African American populations. DATES: Written comments must be received on or before May 23, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0032 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. [[Page 15726]] 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 HIV Knowledge, Beliefs, Attitudes, and Practices of Providers in the Southeast (K-BAP Study)--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Persons at high risk of HIV infection have often had one or more contacts with a health care provider within a year of their diagnoses. These health care encounters represent missed opportunities to: (1) Review and discuss sexual health and risk reduction, (2) screen for HIV infection and other STDs, (3) recognize and diagnose acute HIV infection and offer immediate antiretroviral therapy (ART) if indicated, (4) discuss the prevention benefit of treatment (with subsequent referral or prescription) and re-engagement in care, as appropriate, and (5) provide PrEP and nPEP if not infected and at high risk, consistent with current HIV prevention guidelines and recommendations. Health care providers in high-prevalence geographic areas could substantially reduce new HIV infections among the patient populations they serve, as well as their communities. Health care providers are a trusted source of reliable information. They also have the capacity to perform STD/HIV testing and to prescribe medication with appropriate clinical follow-up. Review of the literature published between January 2000 and June 2014 indicates we know little about providers' knowledge, beliefs, attitudes, and practices (K-BAP) in at-risk jurisdictions about HIV risk, HIV diagnosis and antiretroviral drug interventions in these domains, especially primary care providers serving high-risk patients in high-prevalence communities. K-BAP Study is an effort to assess providers' K-BAP using a cross sectional survey in the five priority HIV prevention domains noted above. This K-BAP Study aligns with multiple goals and objectives of the National HIV/AIDS Strategy (NHAS) and CDC's ``winnable battles.'' The project's specific objectives are to (1) Characterize knowledge, beliefs, attitudes, and practices of providers in five key HIV prevention domains in high-HIV prevalence communities with disproportionate numbers of blacks/African Americans, and (2) Educate providers about prevention interventions related to these domains based on survey-identified knowledge, beliefs, attitudes, and practices of providers' deficits. The respondent population of medical providers will be pulled from the Healthcare Data Solutions (HDS) ProviderPRO and MidLevelPRO databases. Respondents will be recruited to participate in the survey through a combination of emails and phone calls. This strategy will consist of four emails spaced one week apart followed by phone calls to non-responders. The emails will explain the purpose of the survey, the availability of continuing education (CE) credits, and the $20 cash token of appreciation. A large two-part internet-based survey will be conducted among a representative random sample of providers in the selected six (6) metropolitan statistical areas (MSAs) with the highest HIV burden among the African American population. Part one of survey will be administered to participants at the beginning of project. The part-one survey findings will used to identify providers' knowledge, beliefs, attitudes, and practices of providers that might require additional educational reinforcement. Based on survey responses, providers will be linked to continuing education (CE) credit-eligible educational modules to improve their educational deficits. The educational modules are all web-based using either video or case-based methods of learning. The length of the course range from 1-3 hours accounting for 0.25--1.0 credit hours. Part two of survey will be administered six months later comprising of only the core questions in part one of survey to assess impact of CE modules on providers' practices regarding HIV prevention and treatment. There are no costs to respondents other than their time. The total annual burden hours are 1,172. [[Page 15727]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in (in hours) respondent Hours) ---------------------------------------------------------------------------------------------------------------- Providers..................... K-BAP Provider 1,827 1 29/60 883 Baseline Screener and Survey. Providers..................... K-BAP Provider 914 1 19/60 289 Follow-Up Screener and Survey. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 1,172 ---------------------------------------------------------------------------------------------------------------- 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. 2016-06707 Filed 3-23-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices 15725
burden per response for completing the service basis. The medical record abstraction process is expected to
mail-in questionnaire is 15 minutes. In abstraction process does entail require follow-up with 1–5 (average of
addition, respondents will be asked to additional recordkeeping burden to 3) health care providers (N = 2004).
provide contact information for all office assistants for health care Findings from this study will be used
health care providers they have seen in providers, who are required to maintain
to inform interventions targeted to reach
the five years prior to their diagnosis records of disclosures of medical
women who are never or rarely screened
with cervical cancer, and to complete a information, e.g., the HIPAA Release
Health Insurance Portability and Form for the CICC study. The estimated for cervical cancer. Study findings will
Accountability Act (HIPAA) Release burden for support activities associated be disseminated through reports,
form that allows study staff to access the with each medical record abstraction is presentations, and publications. Results
medical records maintained by these five minutes. will also be used by participating sites,
providers. For each CICC participant, CDC has identified three states as CDC, and other federal agencies to
the estimated burden per response for potential study sites. Based on improve services provided to women at
the health care provider list and HIPAA preliminary data from their state cancer risk of invasive cervical cancer.
Release form is five minutes. registries, a total of approximately 1,670 OMB approval is requested for two
Third, medical chart abstractors will eligible cervical cancer survivors are years. All personal identifier
collect information from the health care eligible for participation. CDC estimates information will be maintained by the
providers who provided relevant a survey response rate of 50% of across cancer registries where it is stored as
services to study participants in the five the entire sample (N = 835) followed by
part of the standard registry data
years prior to their diagnosis with an 80% acceptance of medical chart
repository. No identifiable information
invasive cervical cancer. The medical verification (N = 668). These estimates
record abstraction process does not yield approximately 668 women with will be collected by CDC or CDC’s main
entail burden to study participants, or to complete data for both surveys and contractor. Participation is voluntary
the medical chart abstractors who will chart verification. For each CICC and there are no costs to respondents
review the medical charts on a fee-for- participant, the medical chart 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)
Invasive cervical cancer survivors .... Case Investigation of Cervical Can- 418 1 15/60 105
cer Study Survey.
HIPAA Release and Listing of med- 314 1 5/60 28
ical providers in last 5 years.
Health care office assistant .............. Support for medical record abstrac- 1,002 1 5/60 84
tion.
Total ........................................... ........................................................... ........................ ........................ ........................ 217
Leroy A. Richardson, SUMMARY: The Centers for Disease metropolitan statistical geographic areas
Chief, Information Collection Review Office, Control and Prevention (CDC), as part of with large at-risk African American
Office of Scientific Integrity, Office of the its continuing efforts to reduce public populations.
Associate Director for Science, Office of the burden and maximize the utility of
Director, Centers for Disease Control and government information, invites the DATES: Written comments must be
Prevention. received on or before May 23, 2016.
general public and other Federal
[FR Doc. 2016–06706 Filed 3–23–16; 8:45 am]
agencies to take this opportunity to ADDRESSES: You may submit comments,
BILLING CODE 4163–18–P comment on proposed and/or identified by Docket No. CDC–2016–
continuing information collections, as 0032 by any of the following methods:
required by the Paperwork Reduction • Federal eRulemaking Portal:
DEPARTMENT OF HEALTH AND Act of 1995. This notice invites
HUMAN SERVICES Regulation.gov. Follow the instructions
comment on a proposed information for submitting comments.
Centers for Disease Control and collection request entitled ‘‘HIV
Knowledge, Beliefs, Attitudes, and • Mail: Leroy A. Richardson,
Prevention Information Collection Review Office,
Practices of Providers in the Southeast
(K–BAP Study)’’. CDC is requesting a Centers for Disease Control and
[60Day–16–16VB; Docket No. CDC–2016– Prevention, 1600 Clifton Road NE., MS–
three-year approval for new data
0032] D74, Atlanta, Georgia 30329.
collection to identify areas of HIV
prevention knowledge and practice Instructions: All submissions received
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Proposed Data Collection Submitted
for Public Comment and strengths and deficits among primary must include the agency name and
Recommendations care providers, in order to target limited Docket Number. All relevant comments
HIV prevention resources to achieve the received will be posted without change
AGENCY: Centers for Disease Control and greatest reduction in new HIV infections to Regulations.gov, including any
Prevention (CDC), Department of Health and optimize HIV clinical care in personal information provided. For
and Human Services (HHS). clinical settings. The target population access to the docket to read background
will be primary care providers documents or comments received, go to
ACTION: Notice with comment period.
practicing in high-prevalence Regulations.gov.
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![Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices 15727
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)
Providers ........................................... K–BAP Provider Baseline Screener 1,827 1 29/60 883
and Survey.
Providers ........................................... K–BAP Provider Follow-Up Screen- 914 1 19/60 289
er and Survey.
Total ........................................... ........................................................... ........................ ........................ ........................ 1,172
Leroy A. Richardson, Spring, MD 20993–0002, PRAStaff@ and sets forth the special controls that
Chief, Information Collection Review Office, fda.hhs.gov. help to provide a reasonable assurance
Office of Scientific Integrity, Office of the of the safety and effectiveness of devices
Associate Director for Science, Office of the SUPPLEMENTARY INFORMATION: In
classified under that regulation. The
Director, Centers for Disease Control and compliance with 44 U.S.C. 3507, FDA
regulation refers to the special controls
Prevention. has submitted the following proposed
guidance document entitled ‘‘Class II
[FR Doc. 2016–06707 Filed 3–23–16; 8:45 am] collection of information to OMB for
Special Controls Guidance Document:
review and clearance.
BILLING CODE 4163–18–P Reagents for Detection of Specific Novel
Guidance on Reagents for Detection of Influenza A Viruses,’’ which provides
Specific Novel Influenza A Viruses—21 recommendations for measures to help
DEPARTMENT OF HEALTH AND CFR Part 866 OMB Control Number provide a reasonable assurance of safety
HUMAN SERVICES 0910–0584—Extension and effectiveness for these reagents. The
guidance document recommends that
Food and Drug Administration In accordance with section 513 of the
sponsors obtain and analyze postmarket
Federal Food, Drug, and Cosmetic Act
[Docket No. FDA–2015–N–3662] data to ensure the continued reliability
(the FD&C Act) (21 U.S.C. 360c), FDA
of their device in detecting the specific
evaluated an application for an in vitro
Agency Information Collection novel influenza A virus that it is
diagnostic device for detection of
Activities; Submission for Office of intended to detect, particularly given
influenza subtype H5 (Asian lineage),
Management and Budget Review; the propensity for influenza viruses to
commonly known as avian flu. FDA
Comment Request; Guidance on mutate and the potential for changes in
concluded that this device is properly
Reagents for Detection of Specific disease prevalence over time. As
classified into class II in accordance
Novel Influenza A Viruses updated sequences for novel influenza
with section 513(a)(1)(B) of the FD&C A viruses become available from the
AGENCY: Food and Drug Administration, Act, because it is a device for which the World Health Organization, National
HHS. general controls by themselves are Institutes of Health, and other public
ACTION: Notice. insufficient to provide reasonable health entities, sponsors of reagents for
assurance of the safety and effectiveness detection of specific novel influenza A
SUMMARY: The Food and Drug of the device, but there is sufficient viruses will collect this information,
Administration (FDA) is announcing information to establish special controls compare them with the primer/probe
that a proposed collection of to provide such assurance. The statute sequences in their devices, and
information has been submitted to the permits FDA to establish as special incorporate the result of these analyses
Office of Management and Budget controls many different things, into their quality management system,
(OMB) for review and clearance under including postmarket surveillance, as required by 21 CFR 820.100(a)(1).
the Paperwork Reduction Act of 1995. development and dissemination of These analyses will be evaluated against
DATES: Fax written comments on the guidance recommendations, and ‘‘other the device design validation and risk
collection of information by April 25, appropriate actions as the Secretary analysis required by 21 CFR 820.30(g) to
2016. deems necessary’’ (section 513(a)(1)(B) determine if any design changes may be
of the FD&C Act). This information necessary.
ADDRESSES: To ensure that comments on collection is a measure that FDA
the information collection are received, FDA estimates that 10 respondents
determined to be necessary to provide will be affected annually. Each
OMB recommends that written reasonable assurance of safety and
comments be faxed to the Office of respondent will collect this information
effectiveness of reagents for detection of twice per year; each response is
Information and Regulatory Affairs, specific novel influenza A viruses.
OMB, Attn: FDA Desk Officer, FAX: estimated to take 15 hours. This results
FDA issued an order classifying the in a total data collection burden of 300
202–395–7285, or emailed to oira_ H5 (Asian lineage) diagnostic device hours.
submission@omb.eop.gov. All into class II on March 22, 2006 (71 FR The guidance also refers to previously
comments should be identified with the 14377), establishing the special controls approved information collections found
asabaliauskas on DSK3SPTVN1PROD with NOTICES
OMB control number 0910–0584. Also necessary to provide reasonable in FDA regulations. The collections of
include the FDA docket number found assurance of the safety and effectiveness information in 21 CFR part 801 have
in brackets in the heading of this of that device and similar future been approved under OMB control
document. devices. The new classification was number 0910–0485; the collections of
FOR FURTHER INFORMATION CONTACT: FDA codified in 21 CFR 866.3332, a information in 21 CFR part 807 subpart
PRA Staff, Office of Operations, Food regulation that describes the new E have been approved under OMB
and Drug Administration, 8455 classification for reagents for detection control number 0910–0120; and the
Colesville Rd., COLE–14526, Silver of specific novel influenza A viruses collections of information in 21 CFR
VerDate Sep<11>2014 17:44 Mar 23, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\24MRN1.SGM 24MRN1](https://thefederalregister.org/doc/81_FR_15782/page/3.svg)
Document Created: 2016-03-24 00:57:16
Document Modified: 2016-03-24 00:57:16
| 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 May 23, 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 15725 |
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