80 FR 37264 - 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 125 (June 30, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 125 (June 30, 2015)
| Page Range | 37264-37265 | |
| FR Document | 2015-16027 |
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)] [Notices] [Pages 37264-37265] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16027] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60-Day-15-15ARG; Docket No. CDC-2015-0047] 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 ``Prevent Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of this study is to address the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties. DATES: Written comments must be received on or before August 31, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC-2015- 0047 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: omb@cdc.gov. 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 [[Page 37265]] 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 Prevent Hepatitis Transmission Among Persons Who Inject Drugs--New-- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC) Background and Brief Description Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States; approximately 3 million persons are chronically infected. Identifying and reaching persons at risk for HCV infection is critical to prevent transmission and treat and cure if infected. CDC monitors the national incidence of acute hepatitis C through passive surveillance of acute, symptomatic cases of laboratory confirmed hepatitis C cases. Since 2006, surveillance data have shown a trend toward reemergence of HCV infection mainly among young persons who inject drugs (PWID) in nonurban counties. Of the cases reported in 2013 with information on risk factors 62% indicated injection drug use as the primary risk for acute hepatitis C. The prevention of HCV infection among PWIDs requires an integrated approach including harm reduction interventions, substance abuse treatment, prevention of other blood borne infections, and care and treatment of HCV infection. The purpose of the proposed study is to address the high prevalence of HCV infection by developing and implementing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties. Awardees will develop and implement a comprehensive strategy to enroll young non-urban PWID, collect epidemiological information, test for HCV infection and provide linkage to primary care services, prevention interventions, and treatment for substance abuse and HCV infection. In addition to providing HCV testing, participants will be offered testing for the presence of co-infections with hepatitis B virus (HBV) and HIV. Rates of HCV infection or re-infection will be evaluated through follow-up blood tests. Furthermore, adherence to prevention services and retention in care will be assessed through follow up interviews. The project will recruit an estimated total of 1,500 young PWIDs to enroll 1,000. The participants will be recruited from settings where young PWIDs obtain access to care and treatment services. Recruitment will be direct and in-person by partnering with local harm reduction sites. Recruiters will enroll subjects across recruitment sites primarily through drug treatment programs and syringe exchange programs, as well as persons referred to these sites as a result of referral from other programs and respondent driven sampling. Those who consent to participate will be administered an eligibility interview questionnaire by trained field staff. If found eligible, the participant will take an interviewer-administered survey that includes information on initiation of drug use, injection practices, HCV and HIV infection status, access to prevention and medical care, desire to receive and barriers to receiving HCV treatment, and missed opportunities for hepatitis prevention. Participants will receive counselling regarding adherence to medical and/or drug treatment services and prevention services. Participants will be interviewed for a maximum of 5 times within any 12-month interval during the course of the study: Consent and interview at enrollment/baseline for an estimated 60 minutes, and 30-minute follow-up interviews every 3 months thereafter. Participants who are recruited early in the study have more follow-up interviews than those who are recruited in the later part of the study during the 3-year project. However, recruitment will be spread over 2 years and on average, the duration of follow-up is estimated to be one year. Participation in interviews and responses to all study questions are totally voluntary and there is no cost to respondents other than their time. The maximum burden is 3,375 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hrs.) respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Young PWIDs................... Screener........ 1500 1 15/60 375 Eligible young PWIDs.......... Initial Survey.. 1000 1 60/60 1000 Eligible young PWIDs.......... Follow-up survey 1000 4 30/60 2000 --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 3375 ---------------------------------------------------------------------------------------------------------------- Maryam I. Daneshvar, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015-16027 Filed 6-29-15; 8:45 am] BILLING CODE 4163-18-P
![37264 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
such as contact information, social The Director, Management Analysis Docket Number. All relevant comments
security numbers, case numbers, etc., of and Services Office, has been delegated received will be posted without change
the commenter. the authority to sign Federal Register to Regulations.gov, including any
(2) If an individual in making a Notices pertaining to announcements of personal information provided. For
statement reveals personal information meetings and other committee access to the docket to read background
(e.g., medical or employment management activities, for both the documents or comments received, go to
information) about themselves that Centers for Disease Control and Regulations.gov.
information will not usually be Prevention and the Agency for Toxic Please note: All public comment should be
redacted. The NIOSH Freedom of Substances and Disease Registry. submitted through the Federal eRulemaking
Information Act (FOIA) coordinator Elaine L. Baker,
portal (Regulations.gov) or by U.S. mail to the
will, however, review such revelations address listed above.
Director, Management Analysis and Services
in accordance with the Federal Office, Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: To
Advisory Committee Act and if deemed Prevention. request more information on the
appropriate, will redact such [FR Doc. 2015–15925 Filed 6–29–15; 8:45 am] proposed project or to obtain a copy of
information. BILLING CODE 4163–18–P the information collection plan and
(3) If a commenter reveals personal instruments, contact the Information
information concerning a living third Collection Review Office, Centers for
party, that information will be reviewed DEPARTMENT OF HEALTH AND Disease Control and Prevention, 1600
by the NIOSH FOIA coordinator, and HUMAN SERVICES Clifton Road NE., MS–D74, Atlanta,
upon determination, if deemed Georgia 30329; phone: 404–639–7570;
appropriated, such information will be Centers for Disease Control and Email: omb@cdc.gov.
redacted, unless the disclosure is made Prevention SUPPLEMENTARY INFORMATION: Under the
by the third party’s authorized [60–Day–15–15ARG; Docket No. CDC–2015– Paperwork Reduction Act of 1995 (PRA)
representative under the Energy 0047] (44 U.S.C. 3501–3520), Federal agencies
Employees Occupational Illness must obtain approval from the Office of
Compensation Program Act (EEOICPA) Proposed Data Collection Submitted Management and Budget (OMB) for each
program. for Public Comment and collection of information they conduct
(4) In general, information concerning Recommendations or sponsor. In addition, the PRA also
a deceased third party may be disclosed; requires Federal agencies to provide a
AGENCY: Centers for Disease Control and
however, such information will be 60-day notice in the Federal Register
Prevention (CDC), Department of Health
redacted if (a) the disclosure is made by concerning each proposed collection of
and Human Services (HHS).
an individual other than the survivor information, including each new
ACTION: Notice with comment period.
claimant, a parent, spouse, or child, or proposed collection, each proposed
the authorized representative of the SUMMARY: The Centers for Disease extension of existing collection of
deceased third party; (b) if it is unclear Control and Prevention (CDC), as part of information, and each reinstatement of
whether the third party is living or its continuing efforts to reduce public previously approved information
deceased; or (c) the information is burden and maximize the utility of collection before submitting the
unrelated or irrelevant to the purpose of government information, invites the collection to OMB for approval. To
the disclosure. general public and other Federal comply with this requirement, we are
The Board will take reasonable steps agencies to take this opportunity to publishing this notice of a proposed
to ensure that individuals making comment on proposed and/or data collection as described below.
public comment are aware of the fact continuing information collections, as Comments are invited on: (a) Whether
that their comments (including their required by the Paperwork Reduction the proposed collection of information
name, if provided) will appear in a Act of 1995. This notice invites is necessary for the proper performance
transcript of the meeting posted on a comment on ‘‘Prevent Hepatitis of the functions of the agency, including
public Web site. Such reasonable steps Transmission among Persons Who Inject whether the information shall have
include: (a) A statement read at the start Drugs’’. The purpose of this study is to practical utility; (b) the accuracy of the
of each public comment period stating address the high prevalence of HCV agency’s estimate of the burden of the
that transcripts will be posted and infection by developing an integrated proposed collection of information; (c)
names of speakers will not be redacted; approach for detection, prevention, care ways to enhance the quality, utility, and
(b) A printed copy of the statement and treatment of infection among clarity of the information to be
mentioned in (a) above will be persons aged 18–30 years who reside in collected; (d) ways to minimize the
displayed on the table where non-urban counties. burden of the collection of information
individuals sign up to make public DATES: Written comments must be on respondents, including through the
comments; (c) A statement such as received on or before August 31, 2015. use of automated collection techniques
outlined in (a) above will also appear ADDRESSES: You may submit comments, or other forms of information
with the agenda for a Board Meeting identified by Docket No. CDC–2015– technology; and (e) estimates of capital
when it is posted on the NIOSH Web 0047 by any of the following methods: or start-up costs and costs of operation,
site; (d) A statement such as in (a) above • Federal eRulemaking Portal: maintenance, and purchase of services
will appear in the Federal Register to provide information. Burden means
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Regulation.gov. Follow the instructions
Notice that announces Board and for submitting comments. the total time, effort, or financial
Subcommittee meetings. • Mail: Leroy A. Richardson, resources expended by persons to
Contact Person for More Information: Information Collection Review Office, generate, maintain, retain, disclose or
Theodore Katz, Designated Federal Centers for Disease Control and provide information to or for a Federal
Officer, NIOSH, CDC, 1600 Clifton Road Prevention, 1600 Clifton Road, NE., agency. This includes the time needed
NE., MS E–20, Atlanta, Georgia 30333, MS–D74, Atlanta, Georgia 30329. to review instructions; to develop,
telephone: (513) 533–6800, toll free: 1– Instructions: All submissions received acquire, install and utilize technology
800–CDC–INFO, email: dcas@cdc.gov. must include the agency name and and systems for the purpose of
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![Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37265
collecting, validating and verifying primary risk for acute hepatitis C. The primarily through drug treatment
information, processing and prevention of HCV infection among programs and syringe exchange
maintaining information, and disclosing PWIDs requires an integrated approach programs, as well as persons referred to
and providing information; to train including harm reduction interventions, these sites as a result of referral from
personnel and to be able to respond to substance abuse treatment, prevention other programs and respondent driven
a collection of information, to search of other blood borne infections, and care sampling. Those who consent to
data sources, to complete and review and treatment of HCV infection. participate will be administered an
the collection of information; and to The purpose of the proposed study is eligibility interview questionnaire by
transmit or otherwise disclose the to address the high prevalence of HCV trained field staff. If found eligible, the
information. infection by developing and participant will take an interviewer-
implementing an integrated approach administered survey that includes
Proposed Project
for detection, prevention, care and information on initiation of drug use,
Prevent Hepatitis Transmission Among treatment of infection among persons injection practices, HCV and HIV
Persons Who Inject Drugs—New— aged 18–30 years who reside in non- infection status, access to prevention
National Center for HIV/AIDS, Viral urban counties. Awardees will develop and medical care, desire to receive and
Hepatitis, STD, and TB Prevention and implement a comprehensive barriers to receiving HCV treatment, and
(NCHHSTP), Centers for Disease strategy to enroll young non-urban missed opportunities for hepatitis
Control and Prevention (CDC) PWID, collect epidemiological prevention. Participants will receive
Background and Brief Description information, test for HCV infection and counselling regarding adherence to
provide linkage to primary care services, medical and/or drug treatment services
Hepatitis C virus (HCV) infection is prevention interventions, and treatment and prevention services. Participants
the most common chronic blood borne for substance abuse and HCV infection. will be interviewed for a maximum of
infection in the United States; In addition to providing HCV testing, 5 times within any 12-month interval
approximately 3 million persons are participants will be offered testing for during the course of the study: Consent
chronically infected. Identifying and the presence of co-infections with and interview at enrollment/baseline for
reaching persons at risk for HCV hepatitis B virus (HBV) and HIV. Rates an estimated 60 minutes, and 30-minute
infection is critical to prevent of HCV infection or re-infection will be follow-up interviews every 3 months
transmission and treat and cure if evaluated through follow-up blood tests. thereafter. Participants who are
infected. CDC monitors the national Furthermore, adherence to prevention recruited early in the study have more
incidence of acute hepatitis C through services and retention in care will be follow-up interviews than those who are
passive surveillance of acute, assessed through follow up interviews. recruited in the later part of the study
symptomatic cases of laboratory The project will recruit an estimated during the 3-year project. However,
confirmed hepatitis C cases. Since 2006, total of 1,500 young PWIDs to enroll recruitment will be spread over 2 years
surveillance data have shown a trend 1,000. The participants will be recruited and on average, the duration of follow-
toward reemergence of HCV infection from settings where young PWIDs up is estimated to be one year.
mainly among young persons who inject obtain access to care and treatment Participation in interviews and
drugs (PWID) in nonurban counties. Of services. Recruitment will be direct and responses to all study questions are
the cases reported in 2013 with in-person by partnering with local harm totally voluntary and there is no cost to
information on risk factors 62% reduction sites. Recruiters will enroll respondents other than their time. The
indicated injection drug use as the subjects across recruitment sites maximum burden is 3,375 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents respondent response (in hrs.)
(in hrs.)
Young PWIDs ................................... Screener ........................................... 1500 1 15/60 375
Eligible young PWIDs ....................... Initial Survey ..................................... 1000 1 60/60 1000
Eligible young PWIDs ....................... Follow-up survey .............................. 1000 4 30/60 2000
Total ........................................... ........................................................... ........................ ........................ ........................ 3375
Maryam I. Daneshvar, DEPARTMENT OF HEALTH AND ACTION: Notice with comment period.
Deputy Director, Office of Scientific Integrity, HUMAN SERVICES
Office of the Associate Director for Science, SUMMARY: The Centers for Disease
Office of the Director, Centers for Disease Centers for Disease Control and Control and Prevention (CDC), as part of
Control and Prevention. Prevention its continuing efforts to reduce public
[FR Doc. 2015–16027 Filed 6–29–15; 8:45 am]
burden and maximize the utility of
[60Day–15–0666; Docket No. CDC–2015– government information, invites the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4163–18–P 0048] general public and other Federal
agencies to take this opportunity to
Proposed Data Collection Submitted
comment on proposed and/or
for Public Comment and
continuing information collections, as
Recommendations
required by the Paperwork Reduction
AGENCY: Centers for Disease Control and Act of 1995. This notice invites
Prevention (CDC), Department of Health comment on the National Healthcare
and Human Services (HHS). Safety Network (NHSN). NHSN is a
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Document Created: 2018-02-22 11:17:05
Document Modified: 2018-02-22 11:17:05
| 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 August 31, 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 37264 |
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