83 FR 55549 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 215 (November 6, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 215 (November 6, 2018)
| Page Range | 55549-55551 | |
| FR Document | 2018-24231 |
[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)] [Notices] [Pages 55549-55551] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24231] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-19-18AEJ] 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 titled Natural History of Clostridium difficile Colonization and Infection 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 May 29, 2018 to obtain comments from the public and affected agencies. CDC received one comment 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 [email protected]. 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. [[Page 55550]] Proposed Project Natural History of Clostridium difficile Colonization and Infection--New--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description A broad 60-day notice was published in the Federal Register on May 29, 2018, Vol. 83, No. 103, pp. 24475-24476. This 60-day notice notified the public of the broad agency announcement--Applied Research to Address Emerging Public Health Priorities--being made by CDC. Though not specific to this project, it informed the public of CDC's intent to contract with researchers to carry out a variety of different research projects. Current estimates from the CDC suggest that Clostridium difficile now causes more healthcare-associated infections than any other pathogen. However, only 10% to 60% of those acquiring colonization with toxigenic strains develop C. difficile infection (CDI), with the remainder becoming asymptomatic carriers. Current infection control measures focus almost entirely on patients with CDI, but several recent studies suggest that asymptomatic carriers of toxigenic C. difficile may be an under-appreciated source of transmission. Unfortunately, the natural history of C. difficile colonization is not well described because previous studies have not included long-term follow-up of colonized patients and have not included strain-specific information. Previous studies of C. difficile carriage have also rarely included assessments of the burden of carriage, the frequency of skin and environmental shedding, and the impact of antibiotics and other healthcare exposures on colonization. The primary goal of this project is to develop a better understanding of the natural history of C. difficile colonization and infection to develop more effective control measures. The study will answer several questions. How often do patients acquire C. difficile colonization and shed the organism in their stool? Once colonization is acquired, how long do patients continue to shed C. difficile in their stool? How often do patients who acquire C. difficile colonization develop diarrhea? Are some types of C. difficile strains more likely to cause diarrhea or more likely to be shed in stool for a long time? Finally, do factors like antibiotic treatment, other medications, and diet affect the duration and amount of C. difficile shed in stool? The results of the study will be used in the design of interventions to prevent transmission by asymptomatic carriers. The findings will be valuable for development of accurate transmission models including estimation of the effects of prevention interventions and the data will be made available for development of mathematical models of C. difficile transmission. Finally, the study will provide current information on the incubation period for CDI and the fraction of carriers that progress to CDI. The study hospitals will include the Cleveland VA Medical Center, MetroHealth Medical Center, and the Medical University of South Carolina (MUSC). We will conduct a one-year cohort study of 1200 total patients, including 800 admitted to the hospital, 300 admitted to a long-term care facility (LTCF), and 100 outpatients with no healthcare admissions within 3 months. Peri-rectal, groin, chest/abdomen/hand, and environmental swabs will be collected weekly while in the hospital or LTCF for up to 4 weeks; for outpatients, swabs will be collected weekly for up to 4 weeks. Our goal will be to identify patients with new acquisition of toxigenic C. difficile carriage to study the natural history of carriage. Based on previous studies, we anticipate that ~12% of patients will acquire colonization (145 total). For patients with new acquisition of carriage, additional swabs will be collected up to once each month for six months to determine the natural history of colonization and if CDI is diagnosed, stool specimens will be cultured. One of our goals is to determine the impact of a variety of factors including antibiotic therapy, medications (e.g., laxatives), diet, and strain type on duration and burden of C. difficile colonization. In addition, we will obtain information regarding symptoms of diarrhea. To obtain this information, we will perform chart review and interviews. For all subjects, chart review will be conducted during and after admission to obtain information on demographics, co-morbidities, prior CDI, ward location, devices, incontinence, bathing practices, proton pump inhibitor use, mobility, diarrhea, laxatives, and antibiotics (categorized based upon anti-anaerobic and anti-C. difficile activity). To supplement information from chart review, subjects will be interviewed by study personnel at the time of each culture collection to obtain information on diarrhea, medications including antibiotics, proton pump inhibitors, and laxatives, diet, bathing practices, and fecal incontinence. The information being collected through chart review and interviews will be valuable to identify factors associated with C. difficile colonization and infection. If this information were not collected, we would not be able to adequately assess factors that could affect C. difficile colonization or infection and/or that could lead to gastrointestinal symptoms. To supplement information from chart review, subjects will be interviewed by study personnel (contractors) at the time of each culture collection to obtain information on diarrhea, medications including antibiotics, proton pump inhibitors, and laxatives, diet, bathing practices, and fecal incontinence. The questions will be administered by study personnel who will be trained by the principal investigator or co-investigators. All subjects will be interviewed. The respondents will have advance notice or appointments. Total annualized Burden Hours for this study are 577. There is no burden on respondents other than the time to participate. Authorizing legislation comes from Section 301 of the Public Health Service Act. CDC is seeking one year of clearance to complete this study. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Study participants.................... Questionnaire........... 1200 5 5/60 Subjects acquiring C. difficile Questionnaire........... 145 6 5/60 colonization. Subjects developing CDI............... Questionnaire........... 48 1 5/60 ---------------------------------------------------------------------------------------------------------------- [[Page 55551]] Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2018-24231 Filed 11-5-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices 55549
respondents. Seven-month quit rates quitline service providers, using the and the CDC Tips From Former Smokers
have been previously estimated for all NQDW Quitline Services Survey. national tobacco education media
Quitline callers except those that call Data collected from the NQDW is campaigns on state quitline call volume
the ASQ. Based on previous literature analyzed with simple descriptive data and tobacco users receiving services
and a review of the follow-up evaluation tabulations, and trends are currently from state quitlines.
data previously collected by the NQDW, reported online through the CDC State
Tobacco Activities Tracking and CDC uses the information collected by
seven-month quit rates are not expected the NQDW for ongoing monitoring,
to change significantly over time. Data Evaluation (STATE) System website.
More complex statistical analyses, reporting, and evaluation related to state
on the quitline call volume, number of quitlines. Select data from the NQDW
including multivariate regression
tobacco users served, and the services are reported online through the CDC’s
techniques will be utilized to assess
offered by state quitlines will be quitline outcomes such as quitline STATE System website (http://
provided by state health department reach, service utilization, how callers www.cdc.gov/statesystem). The total
personnel who manage the quitline, or reported hearing about the quitline, and estimated annual Burden Hours for
their designee, such as contracted the effectiveness of quitline promotions NQDW are 82,477.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents respondent (in hours)
respondent (in hours)
Quitline callers who contact the NQDW Intake Questionnaire 488,846 1 10/60 81,474
quitline for help for themselves. (English-complete).
ASQ Intake Questionnaire (Chinese, 1,935 1 10/60 323
Korean, or Vietnamese-complete).
ASQ Seven-Month Follow-up Ques- 1,587 1 7/60 185
tionnaire.
Caller who contacts the Quitline on NQDW Intake Questionnaire 12,217 1 1/60 204
behalf of someone else. (English-subset).
ASQ Intake Questionnaire (Chinese, 86 1 1/60 2
Korean, or Vietnamese-subset).
Tobacco Control Manager or their Submission of NQDW Intake Ques- 54 4 1 216
Designee/Quitline Service Provider. tionnaire Electronic Data File to
CDC.
Submission of NQDW (ASQ) 1 1 1 1
Seven-Month Follow-up Electronic
Data File to CDC.
NQDW Quitline Services Survey ..... 54 4 20/60 72
Total ........................................... ........................................................... ........................ ........................ ........................ 82,477
Jeffrey M. Zirger, ‘‘Proposed Data Collection Submitted (c) Enhance the quality, utility, and
Acting Lead, Information Collection Review for Public Comment and clarity of the information to be
Office, Office of Scientific Integrity, Office Recommendations’’ notice on May 29, collected;
of Science, Centers for Disease Control and 2018 to obtain comments from the (d) Minimize the burden of the
Prevention.
public and affected agencies. CDC collection of information on those who
[FR Doc. 2018–24232 Filed 11–5–18; 8:45 am] are to respond, including, through the
received one comment related to the
BILLING CODE 4163–18–P
previous notice. This notice serves to use of appropriate automated,
allow an additional 30 days for public electronic, mechanical, or other
and affected agency comments. technological collection techniques or
DEPARTMENT OF HEALTH AND other forms of information technology,
HUMAN SERVICES CDC will accept all comments for this e.g., permitting electronic submission of
proposed information collection project. responses; and
Centers for Disease Control and The Office of Management and Budget
Prevention (e) Assess information collection
is particularly interested in comments costs.
[30Day–19–18AEJ] that: To request additional information on
(a) Evaluate whether the proposed the proposed project or to obtain a copy
Agency Forms Undergoing Paperwork
collection of information is necessary of the information collection plan and
Reduction Act Review
for the proper performance of the instruments, call (404) 639–7570 or
In accordance with the Paperwork functions of the agency, including send an email to omb@cdc.gov. Direct
Reduction Act of 1995, the Centers for written comments and/or suggestions
khammond on DSK30JT082PROD with NOTICES
whether the information will have
Disease Control and Prevention (CDC) practical utility; regarding the items contained in this
has submitted the information notice to the Attention: CDC Desk
(b) Evaluate the accuracy of the
collection request titled Natural History Officer, Office of Management and
agencies estimate of the burden of the
of Clostridium difficile Colonization and Budget, 725 17th Street NW,
Infection to the Office of Management proposed collection of information, Washington, DC 20503 or by fax to (202)
and Budget (OMB) for review and including the validity of the 395–5806. Provide written comments
approval. CDC previously published a methodology and assumptions used; within 30 days of notice publication.
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![Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices 55551
Jeffrey M. Zirger, Corrective Action Documentation provide reasonable cause justifications
Acting Lead, Information Collection Review Process—Final. as to why a penalty should not be
Office, Office of Scientific Integrity, Office OMB No.: 0970–0215. imposed or may develop and implement
of Science, Centers for Disease Control and Description: 42 U.S.C. 612 (Section corrective compliance procedures to
Prevention.
412 of the Social Security Act as eliminate the source of the penalty.
[FR Doc. 2018–24231 Filed 11–5–18; 8:45 am] amended by Public Law 104–193, the Finally, there is an annual report, which
BILLING CODE 4163–18–P Personal Responsibility and Work requires the Tribes to describe program
Opportunity Reconciliation Act of 1996 characteristics. All of the above
(PRWORA)), mandates that federally requirements are currently approved by
DEPARTMENT OF HEALTH AND recognized Indian Tribes with an
HUMAN SERVICES OMB and the Administration for
approved Tribal TANF program collect Children and Families is simply
Administration for Children and and submit to the Secretary of the proposing to extend them without any
Families Department of Health and Human changes.
Services data on the recipients served
Proposed Information Collection by the Tribes’ programs. This Respondents: Indian Tribes.
Activity; Comment Request information includes both aggregated
and disaggregated data on case
Proposed Projects characteristics and individual
Title: Tribal TANF Data Report, TANF characteristics. In addition, Tribes that
Annual Report, and Reasonable Cause/ are subject to a penalty are allowed to
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Final Tribal TANF Data Report ........................................................................ 74 4 451 133,496
Tribal TANF Annual Report ............................................................................. 74 1 40 2,960
Tribal TANF Reasonable Cause/Corrective .................................................... 74 1 60 4,440
Estimated Total Annual Burden other forms of information technology. Answers and provides answers to
Hours: 140,896. Consideration will be given to common questions that might arise
In compliance with the requirements comments and suggestions submitted about the mandatory recall provisions
of Section 506(c)(2)(A) of the Paperwork within 60 days of this publication. and FDA’s plans for their
Reduction Act of 1995, the implementation.
Robert Sargis,
Administration for Children and DATES: The announcement of the
Reports Clearance Officer.
Families is soliciting public comment guidance is published in the Federal
on the specific aspects of the [FR Doc. 2018–24259 Filed 11–5–18; 8:45 am]
Register on November 6, 2018.
information collection described above. BILLING CODE 4184–01–P
ADDRESSES: You may submit either
Copies of the proposed collection of electronic or written comments on
information can be obtained and Agency guidances at any time as
comments may be forwarded by writing DEPARTMENT OF HEALTH AND
HUMAN SERVICES follows:
to the Administration for Children and
Families, Office of Planning, Research Electronic Submissions
Food and Drug Administration
and Evaluation, 330 C Street SW, Submit electronic comments in the
Washington, DC 20201, Attn: ACF [Docket No. FDA–2015–D–0138] following way:
Reports Clearance Officer. Email • Federal eRulemaking Portal:
address: infocollection@acf.hhs.gov. All Questions and Answers Regarding https://www.regulations.gov. Follow the
requests should be identified by the title Mandatory Food Recalls: Guidance for instructions for submitting comments.
of the information collection. Industry and Food and Drug Comments submitted electronically,
The Department specifically requests Administration Staff; Availability including attachments, to https://
comments on: (a) Whether the proposed AGENCY: Food and Drug Administration, www.regulations.gov will be posted to
collection of information is necessary HHS. the docket unchanged. Because your
for the proper performance of the ACTION: Notice of availability. comment will be made public, you are
functions of the agency, including solely responsible for ensuring that your
whether the information shall have SUMMARY: The Food and Drug comment does not include any
practical utility; (b) the accuracy of the Administration (FDA or we) is confidential information that you or a
agency’s estimate of the burden of the announcing the availability of a final third party may not wish to be posted,
proposed collection of information; (c) guidance for industry and FDA staff such as medical information, your or
the quality, utility, and clarity of the entitled ‘‘Questions and Answers anyone else’s Social Security number, or
khammond on DSK30JT082PROD with NOTICES
information to be collected; and (d) Regarding Mandatory Food Recalls: confidential business information, such
ways to minimize the burden Guidance for Industry and FDA Staff.’’ as a manufacturing process. Please note
information to be collected; and (d) The guidance provides information on that if you include your name, contact
ways to minimize the burden of the the implementation of the mandatory information, or other information that
collection of information on food recall provisions of the FDA Food identifies you in the body of your
respondents, including through the use Safety Modernization Act (FSMA). The comments, that information will be
of automated collection techniques or guidance is in the form of Questions and posted on https://www.regulations.gov.
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Document Created: 2018-11-06 00:18:24
Document Modified: 2018-11-06 00:18:24
| 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 55549 |
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