83 FR 34583 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 140 (July 20, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 140 (July 20, 2018)
| Page Range | 34583-34585 | |
| FR Document | 2018-15525 |
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)] [Notices] [Pages 34583-34585] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15525] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-18-0307] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request Gonococcal Isolate Surveillance Project to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ``Proposed Data Collection Submitted for Public Comment and Recommendations'' notice on February 5, 2018 to obtain comments from the public and affected agencies. The CDC received 2 non- substantive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Gonococcal Isolate Surveillance Project (0920-0307) (Exp. Date 02/ 28/2019)--Revision--National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Gonococcal Isolate Surveillance Project (GISP) was created in 1986 to monitor trends in antimicrobial susceptibilities of Neisseria gonorrhoeae strains in the United States. GISP continues to be a collaboration between different branches of the CDC Division of STD Prevention within the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), selected regional laboratories and selected state/local public health departments and their associated STD specialty care clinics in the U.S. National organizations, local jurisdictions and individuals use data collected in GISP to understand and prevent antibiotic resistance in N. gonorrhoeae. Data from GISP are used to establish a scientific basis for the selection of gonococcal therapies and to allow pro-active changes to treatment guidelines before widespread resistance and failures of treatment occur. To increase capacity to detect and monitor resistant gonorrhea and to improve the specificity of GISP, this revision is being [[Page 34584]] submitted to include collection of additional isolates and data elements. In the current approval period, GISP isolates are only collected from males and include <4% of reported male gonorrhea cases in the United States. This relatively limited scope likely limits the speed with which new resistance patterns are found and with which public health officials can respond. Published data suggest that resistance in N. gonorrhoeae might develop initially in non-genital anatomic sites, such as the pharynx. It has also been hypothesized that susceptibility patterns may be different among women. Upon receiving OMB approval of the revision request, CDC plans to begin including isolates from the pharynx and other anatomic sites, as well as from women. These changes are expected to support public health efforts to detect and respond to resistance more quickly. GISP surveillance can also be strengthened by ensuring that GISP surveillance is only being conducted on N. gonorrhoeae and not on other similar bacteria. Neisseria meningitidis can cause clinical syndromes that are indistinguishable from gonorrhea. Using nucleic acid amplification tests (a more specific diagnostic test) in conjunction with bacterial culture from all anatomic sites can ensure that non- gonococcal bacteria are excluded from GISP data. This is expected to strengthen the accuracy and usefulness of GISP data. Historically, healthcare providers at approximately 30 participating sentinel sites (i.e., STD clinic or multiple STD clinics affiliated with a single public health department) obtain urethral N. gonorrhoeae isolates from the first 25 men with urethral gonorrhea each month with occasional month-to-month variability. With this revision, we are now asking for a subset of sentinel sites (10 out of 30 sites) to conduct enhanced surveillance activities, collecting additional isolates (including from the pharynx, rectum, and cervix of exposed persons) with a limited number of additional data elements. We anticipate that approximately 50 additional isolates per month will be collected by each of these 10 sites (total of approximately 70 isolates per month per enhanced surveillance site). All isolates will be shipped each month to a regional laboratory for antimicrobial susceptibility testing. When isolates that appear to be bacteria other than N. gonorrhoeae are identified at one of the ten sentinel sites conducting enhanced surveillance, the isolate will be shipped to the regional laboratory and then to CDC. Based on informal discussions with current GISP sentinel sites, we anticipate that approximately 10 such isolates will be identified at each site per year. Sentinel sites that are not part of this small subset will continue to function as they already are. Under this revision, the data collection and reporting processes have been streamlined to minimize burden. All demographic/clinical data from the sentinel sites, and antimicrobial susceptibility testing results from the regional laboratories, will be submitted electronically (1) directly from the sentinel site to the GISP data manager at CDC through a secure data portal, (2) through a secure GISP- web based application, or (3) through the CDC Secure Access Management Services partner portal. To minimize burden, comma-separated values (csv) files that provide standardized structure of the electronic data are provided to sentinel sites and laboratories. Additionally, to further minimize burden, the regional laboratories will be able to extract electronic data from electronic laboratory information systems instead of hand entering data and will no longer be required to report control strain testing results. This project will not collect name, social security number, or date of birth. A Patient ID, a unique patient identifier assigned by the site that allows for linking of multiple isolates from a single person at a single clinic visit and across multiple clinic visits, is requested and will be provided to CDC for purposes of enhanced surveillance. Sensitive information such as sex of sex partners, HIV status, sex work exposure, and injection drug use are collected. Patient data are obtained through review of medical records by the clinic staff and included in collection reporting of demographic/ clinical information. All personally identifiable information (PII) is retained by the STD clinics that treated the patient and is not recorded with data sent to CDC or regional laboratories. At sites where enhanced surveillance will not occur isolates are collected from patients as part of their routine care when a gonorrhea infection is suspected. The electronic GISP database is stored on the CDC mainframe computer and only approved Division of STD Prevention (DSTDP) staff have access rights to the data. As part of the revision, we will continue to systematically identify the risks and potential effects of collecting, maintaining, and disseminating PII and to examine and evaluate alternative processes for handling that information to mitigate potential privacy risks and risks to confidentiality. The CDC has designated N. gonorrhoeae as one of three ``urgent'' antibiotic resistance threats in the United States. The CDC is requesting a three-year OMB approval for this revision, which directly responds to the National Strategy for Combating Antibiotic Resistant Bacteria by improving and strengthening surveillance of antimicrobial resistance through GISP. This GISP data can help monitor and evaluate the effectiveness of public health interventions conducted to support the National Strategy for Combating Antibiotic-Resistant Bacteria. Sentinel sites and regional laboratories voluntarily apply to participate in the GISP cooperative agreement program. Once funded, participation in the GISP information collection and isolate processing plan is required. The total estimated annualized burden hours are 11,376. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Sentinel site conducting core Demographic/Clinical 20 240 11/60 surveillance. Data. Sentinel site conducting enhanced Demographic/Clinical 10 840 12/60 surveillance. Data. Regional laboratory................... Antimicrobial 4 3,300 40/60 Susceptibility Testing Results. Regional laboratory................... Control Strain 4 48 5/60 Susceptibility Testing. ---------------------------------------------------------------------------------------------------------------- [[Page 34585]] Jeffrey M. Zirger, Acting 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. 2018-15525 Filed 7-19-18; 8:45 am] BILLING CODE 4163-18-P
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proposing to relocate and consolidate its the comments are provided in the Final (b) Evaluate the accuracy of the
Cincinnati-based functions and EIS. No comment required substantive agencies estimate of the burden of the
personnel (approximately 550 revisions to the analyses presented in proposed collection of information,
employees) currently housed at the the Draft EIS or to the alternatives including the validity of the
three existing campuses to a new, considered. The Final EIS identifies the methodology and assumptions used;
consolidated campus in Cincinnati. Proposed Action Alternative as CDC’s (c) Enhance the quality, utility, and
Potential locations for the proposed Preferred Alternative. clarity of the information to be
new campus were identified through a CDC will make a decision on whether collected;
comprehensive site selection process to proceed with the proposed action (d) Minimize the burden of the
conducted by GSA on behalf of CDC. In after August 20, 2018. At that time, CDC collection of information on those who
June 2016, GSA issued a Request for will issue a Record of Decision are to respond, including, through the
Expressions of Interest (REOI) seeking documenting and explaining its use of appropriate automated,
potential sites capable of decision based on the Final EIS. electronic, mechanical, or other
accommodating the proposed new Questions on the Final EIS and the technological collection techniques or
campus. In response to the REOI, GSA proposed action may be directed to: other forms of information technology,
received seven expressions of interest. Harry Marsh, Architect, Office of Safety, e.g., permitting electronic submission of
Following an assessment of each site, Security and Asset Management responses; and
GSA found that only one site qualified (OSSAM), Centers for Disease Control (e) Assess information collection
for further consideration (The Site). The and Prevention, 1600 Clifton Road NE, costs.
Site encompasses all land between MS–K80, Atlanta, Georgia 30329–4027, To request additional information on
Martin Luther King Drive East to the phone: (770) 488–8170, or email: cdc- the proposed project or to obtain a copy
south, Harvey Avenue to the west, cincinnati-eis@cdc.gov. of the information collection plan and
Ridgeway Avenue to the north, and Dated: July 16, 2018. instruments, call (404) 639–7570 or
Reading Road to the east in Cincinnati, Sandra Cashman,
send an email to omb@cdc.gov. Direct
Ohio. written comments and/or suggestions
Executive Secretary, Centers for Disease
Under NEPA, as implemented by CEQ Control and Prevention. regarding the items contained in this
Regulations (40 CFR parts 1500–1508), notice to the Attention: CDC Desk
[FR Doc. 2018–15410 Filed 7–19–18; 8:45 am]
Federal agencies are required to Officer, Office of Management and
BILLING CODE 4163–18–P
evaluate the environmental effects of Budget, 725 17th Street NW,
their proposed actions and a range of Washington, DC 20503 or by fax to (202)
reasonable alternatives to the proposed DEPARTMENT OF HEALTH AND 395–5806. Provide written comments
action before making a decision. On HUMAN SERVICES within 30 days of notice publication.
February 9, 2018, in accordance with
Proposed Project
NEPA, CDC published a Notice of Centers for Disease Control and
Availability announcing that a Draft EIS Prevention Gonococcal Isolate Surveillance
for the proposed acquisition and Project (0920–0307) (Exp. Date 02/28/
campus consolidation had been [30 Day–18–0307] 2019)—Revision—National Center for
prepared (83 FR 5774). The Draft EIS HIV, Viral Hepatitis, STD, and TB
Agency Forms Undergoing Paperwork Prevention (NCHHSTP), Centers for
evaluated the potential impacts of two
Reduction Act Review
alternatives: The Proposed Action Disease Control and Prevention (CDC).
Alternative (acquisition of the Site and In accordance with the Paperwork Background and Brief Description
construction of a new, consolidated Reduction Act of 1995, the Centers for
CDC/NIOSH campus) and the No Action Disease Control and Prevention (CDC) The Gonococcal Isolate Surveillance
Alternative (continued use of the has submitted the information Project (GISP) was created in 1986 to
existing campuses for the foreseeable collection request Gonococcal Isolate monitor trends in antimicrobial
future). Impacts on the following Surveillance Project to the Office of susceptibilities of Neisseria gonorrhoeae
resources were considered: Land use, Management and Budget (OMB) for strains in the United States. GISP
zoning, and plans; community facilities; review and approval. CDC previously continues to be a collaboration between
socioeconomics and environmental published a ‘‘Proposed Data Collection different branches of the CDC Division
justice; utilities and infrastructure; Submitted for Public Comment and of STD Prevention within the National
visual quality; cultural resources; Recommendations’’ notice on February Center for HIV, Viral Hepatitis, STD,
transportation; geology, topography, and 5, 2018 to obtain comments from the and TB Prevention (NCHHSTP),
soils; air quality; noise; and hazardous public and affected agencies. The CDC selected regional laboratories and
substances. received 2 non-substantive comments selected state/local public health
Publication of the Draft EIS notice related to the previous notice. This departments and their associated STD
initiated a 45-day review period, which notice serves to allow an additional 30 specialty care clinics in the U.S.
ended on March 26, 2018. During this days for public and affected agency National organizations, local
period, CDC received comments from comments. jurisdictions and individuals use data
government agencies, a Native CDC will accept all comments for this collected in GISP to understand and
American tribe, and the public. These proposed information collection project. prevent antibiotic resistance in N.
comments pertained to the proposed The Office of Management and Budget gonorrhoeae. Data from GISP are used to
action in general; the accessibility of the is particularly interested in comments establish a scientific basis for the
daltland on DSKBBV9HB2PROD with NOTICES
proposed campus site for bicyclists; that: selection of gonococcal therapies and to
historic buildings; traffic and air quality (a) Evaluate whether the proposed allow pro-active changes to treatment
impacts; sustainability; and the collection of information is necessary guidelines before widespread resistance
potential displacement of neighborhood for the proper performance of the and failures of treatment occur. To
residents. functions of the agency, including increase capacity to detect and monitor
All comments were considered when whether the information will have resistant gonorrhea and to improve the
preparing the Final EIS and responses to practical utility; specificity of GISP, this revision is being
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Jeffrey M. Zirger, (regulations.gov) or by U.S. mail to the (NIOSH) is responsible for conducting
Acting Chief, Information Collection Review address listed above. research and making recommendations
Office, Office of Scientific Integrity, Office FOR FURTHER INFORMATION CONTACT: To to prevent worker injury and illness, as
of the Associate Director for Science, Office request more information on the authorized in Section 20(a)(1) of the
of the Director, Centers for Disease Control proposed project or to obtain a copy of Occupational Safety and Health Act (29
and Prevention. U.S.C. 669). NIOSH is strongly
the information collection plan and
[FR Doc. 2018–15525 Filed 7–19–18; 8:45 am] committed to program evaluation as a
instruments, contact Jeffrey M. Zirger,
BILLING CODE 4163–18–P Information Collection Review Office, way to maximize its contributions to
Centers for Disease Control and improved occupational safety and
Prevention, 1600 Clifton Road NE, MS– health. NIOSH is requesting a new
DEPARTMENT OF HEALTH AND D74, Atlanta, Georgia 30329; phone: generic information collection request
HUMAN SERVICES 404–639–7570; Email: omb@cdc.gov. for a three-year period that will support
Centers for Disease Control and SUPPLEMENTARY INFORMATION: Under the the timely information collection
Prevention Paperwork Reduction Act of 1995 (PRA) needed for upcoming program
(44 U.S.C. 3501–3520), Federal agencies evaluation activities, such as external
[60Day–18–18AMQ; Docket No. CDC–2018– must obtain approval from the Office of reviews of NIOSH research programs
0061] Management and Budget (OMB) for each (which fulfill a Government
collection of information they conduct Performance and Results Act (GPRA)
Proposed Data Collection Submitted or sponsor. In addition, the PRA also requirement, studies to understand the
for Public Comment and requires Federal agencies to provide a economic value of NIOSH research,
Recommendations 60-day notice in the Federal Register process evaluations of NIOSH programs,
concerning each proposed collection of and evaluations of large research
AGENCY: Centers for Disease Control and information, including each new projects. NIOSH needs to collect
Prevention (CDC), Department of Health proposed collection, each proposed information about research
and Human Services (HHS). extension of existing collection of dissemination and achieved outcomes
ACTION: Notice with comment period. information, and each reinstatement of from key audiences (grantees, potential
previously approved information NIOSH research users and relevant
SUMMARY: The Centers for Disease safety and health experts) for
collection before submitting the
Control and Prevention (CDC), as part of accountability and program
collection to the OMB for approval. To
its continuing effort to reduce public improvement purposes. NIOSH is
comply with this requirement, we are
burden and maximize the utility of specifically interested in assessing
publishing this notice of a proposed
government information, invites the intermediate outcomes—the use of
data collection as described below.
general public and other Federal The OMB is particularly interested in NIOSH research products and findings
agencies the opportunity to comment on comments that will help: by external stakeholders and partners to
a proposed and/or continuing 1. Evaluate whether the proposed improve safety and health—as evidence
information collection, as required by collection of information is necessary of research impact. Being able to collect
the Paperwork Reduction Act of 1995. for the proper performance of the information on intermediate outcomes
This notice invites comment on a functions of the agency, including from grantees, as well as past, present
proposed information collection project whether the information will have and potential future users of NIOSH
titled Assessing impact of the NIOSH practical utility; research would allow us to provide
research. The goal of the generic 2. Evaluate the accuracy of the more robust evidence of use or adoption
information collection request is to agency’s estimate of the burden of the of NIOSH research products or findings.
improve the ability of NIOSH to assess proposed collection of information,
and demonstrate the extent to which its The evaluation findings and
including the validity of the recommendations from the various
various research efforts are likely to or methodology and assumptions used;
have led to improvements in workplace program evaluation activities described
3. Enhance the quality, utility, and above will be used as an input for future
safety and health. clarity of the information to be direction of the programs and
DATES: CDC must receive written collected; and incorporated into analyses and reports
comments on or before September 18, 4. Minimize the burden of the
to either investigate the value of
2018. collection of information on those who
NIOSH’s research, or improve program
are to respond, including through the
ADDRESSES: You may submit comments, operations to maximize impact. Data
use of appropriate automated,
identified by Docket No. CDC–2018– will be collected through semi-
electronic, mechanical, or other
0061 by any of the following methods: structured key informant interviews
technological collection techniques or
• Federal eRulemaking Portal: with grantees, potential or known users
other forms of information technology,
Regulations.gov. Follow the instructions of NIOSH research and subject matter
e.g., permitting electronic submissions
for submitting comments. experts in safety and health. NIOSH
of responses.
• Mail: Jeffrey M. Zirger, Information 5. Assess information collection costs. estimates that 30 respondents will be
Collection Review Office, Centers for involved in phone interviews, which
Disease Control and Prevention, 1600 Proposed Project would last between 30–60 minutes.
Clifton Road NE, MS–D74, Atlanta, Assessing impact of the NIOSH However, participants might be
Georgia 30329. research—New—National Institute for burdened an additional hour reading the
daltland on DSKBBV9HB2PROD with NOTICES
Instructions: All submissions received Occupational Safety and Health invitation email and providing relevant
must include the agency name and (NIOSH), Centers for Disease Control documents such as evidence of research
Docket Number. CDC will post, without and Prevention (CDC). impact. Therefore, the estimated burden
change, all relevant comments to for each participant is two hours. The
Regulations.gov. Background and Brief Description total estimated burden is 60 hours.
Please note: Submit all comments The National Institute for There is no cost to respondents other
through the Federal eRulemaking portal Occupational Safety and Health than their time.
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Document Created: 2018-07-20 01:18:12
Document Modified: 2018-07-20 01:18:12
| 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 | |
| FR Citation | 83 FR 34583 |
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