83 FR 45449 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 174 (September 7, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 174 (September 7, 2018)
| Page Range | 45449-45451 | |
| FR Document | 2018-19381 |
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)] [Notices] [Pages 45449-45451] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19381] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-0134; Docket No. CDC-2018-0078] 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Foreign Quarantine Regulations, an information collection related to illness and death reports from airplanes and maritime vessels coming to the United States, illness and death investigations of travelers, and information from importers of certain items specified under 42 CFR 71 subpart F. DATES: CDC must receive written comments on or before November 6, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0078 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. 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; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. 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 submissions of responses. 5. Assess information collection costs. Proposed Project Foreign Quarantine Regulations (42 CFR 71) (OMB Control No. 0920- 0134) (Exp 5/31/2019)--Revision--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264) (Attachment A1) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the United States. Statute and the existing [[Page 45450]] regulations governing foreign quarantine activities (42 CFR 71) authorize quarantine officers and other personnel to inspect and undertake necessary control measures with respect to conveyances, persons, and shipments of animals and etiologic agents in order to protect the public's health. Other inspection agencies, such as Customs and Border Protection (CBP), assist quarantine officers in public health screening of persons, pets, and other importations of public health importance and make referrals to quarantine station staff when indicated. These practices and procedures ensure protection against the introduction and spread of communicable diseases into and within the United States with a minimum of recordkeeping and reporting procedures, as well as a minimum of interference with trade and travel. U.S. Quarantine Stations are located at 20 ports of entry and land- border crossings where international travelers arrive. The jurisdiction of each station includes air, maritime, and/or land-border ports of entry. Quarantine Station staff work in partnership with international, federal, state, and local agencies and organizations to fulfill their mission to reduce morbidity and mortality among globally mobile populations. This work is performed to prevent the introduction, transmission, and spread of communicable diseases from foreign countries into the United States or from one State or possession to another State or possession. When an illness suggestive of a communicable disease is reported by conveyance operators or port partners (e.g., Customs and Border Protection), Quarantine Officers respond to carry out an onsite public health assessment and collect data from the individual. This response may occur jointly with port partners. The collection of comprehensive, pertinent public health information during these responses enables Quarantine Officers to make an accurate public health assessment and identify appropriate next steps. For this reason, quarantine station staff need to systematically interview ill travelers and collect relevant health and epidemiologic information. CDC is making a number of changes and adjustments to this information collection. The changes are as follows: CDC is merging this information collection with another, 0920-0821 Illness Response Forms: Airline, Maritime, and Land/Border Crossing. CDC is disaggregating the information collection 42 CFR 71.21(a) report of illness or death from ships so that the influenza like illness (ILI) report, which is voluntary, is separate from the required report of ill person or death. CDC is removing the information collection pertaining to Partner Government Agency Message Sets, because CDC will not collect information using these tools. CDC is removing the acute gastroenteritis reports from ships and removal of medical logs information collection from this information collection request, because CDC's Vessel Sanitation Program will submit a separate information collection request for these tools. CDC is requesting the following adjustments As described above, CDC is requesting a separation of the maritime (ILI) and other maritime illness or death reports. CDC is also requesting an increase in the total number of maritime reports of illness of each type, ILI and others. For fall 2018, CDC is considering a policy change related to requirements for rabies vaccination documentation for dogs coming from certain countries; therefore, CDC is providing estimates of burden and respondents related to importation of dogs into the United States. Revised estimates under 42 CFR 71.55, 42 CFR 71.32 Dead Bodies--Death certificates. Revised estimate of the number of requests for exemptions for importation of African rodents. Respondents for this information collection request are any pilot in command of an aircraft or maritime vessel operator. With an ill person meeting certain criteria, or death aboard; any individual who is subject to federal quarantine or isolation; any ill traveler who is reported by the airlines, Customs and Border Protection, or EMS to CDC or the local public health authority that meets the definition of ill person; and any importer or filer who seeks to bring certain animals, animal products, or other CDC-regulated item into the United States. For most of these collections, there are no costs to respondents other than their time. Examinations of imported animals is only required if the pet is ill on arrival or if it has died during transport. These exams are not routine. Depending on the time of arrival, the initial exam fee may be between $100 and $200. Rabies testing on a dog that dies may be between $50 and $100. The expected number of ill or dead dogs arriving into the United States for which CDC may require an examination is estimated at less than 30 per year. CDC is requesting a three-year approval. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Regulatory provision or form name Number of responses per per response Total burden respondents respondent (in hours) hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Maritime Vessel Operator.................. 42 CFR 71.21(a) report of illness or death 500 1 5/60 42 from ships--Maritime Conveyance Illness or Death Investigation Form sections 1-4. Maritime Vessel Operator.................. 42 CFR 71.21(a) report of illness or death 100 1 2/60 3 from ships--Maritime Conveyance Illness or Death Investigation Form section 5. Maritime Vessel Operator.................. Cumulative Influenza/Influenza-Like Illness 3,000 1 2/60 100 (ILI). Pilot in command.......................... 42 CFR 71.21(b) Death/Illness reports from 1,700 1 2/60 57 aircrafts. Traveler.................................. Airline Travel Illness or Death 1,700 1 5/60 142 Investigation Form. Traveler.................................. Land Travel Illness or Death Investigation 100 1 5/60 8 Form. Isolated or Quarantined individuals....... 42 CFR 71.33 Report by persons in isolation 11 1 3/60 1 or surveillance. Maritime Vessel Operator.................. 42 CFR 71.35 Report of death/illness during 5 1 30/60 3 stay in port. Importer.................................. 42 CFR 71.51(c)(1), (d)--Valid Rabies 113,500 1 15/60 28,375 Vaccination Certificates. Importer.................................. CDC Form 75.37 Notice To Owners And 14 1 10/60 2 Importers Of Dogs: Requirement for Dog Confinement. Importer.................................. 42 CFR 71.51(c)(i), (ii), and (iii) 958,000 1 15/60 239,500 exemption criteria for the importation of a dog without a rabies vaccination certificate. Importer.................................. 42 CFR 71.51(c)(2), (d) Application For 50 1 45/60 38 Permission To Import A Dog Inadequately Against Rabies. Importer.................................. 42 CFR 71.51(b)(3) Dogs/cats: Record of 20 1 15/60 5 sickness or deaths. Importer.................................. 42 CFR 71.52(d) Turtle Importation Permits.. 5 1 30/60 3 [[Page 45451]] Importers................................. 42 CFR 71.55 Dead Bodies, 42 CFR 71.32-- 20 1 1 20 Death certificates. Importer.................................. 42 CFR 71.56 (a)(2) African Rodents--Request 25 1 1 25 for exemption. Importer.................................. 42 CFR 71.56(a)(iii) Appeal................. 2 1 1 2 Importer.................................. 42 CFR 71.32 Statements or documentation of 2,000 1 5/60 167 non-infectiousness. --------------------------------------------------------------- Total................................. ............................................ .............. .............. .............. 268,493 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. 2018-19381 Filed 9-6-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45449
members are Special Government DEPARTMENT OF HEALTH AND Prevention, 1600 Clifton Road NE, MS–
Employees, requiring the filing of HUMAN SERVICES D74, Atlanta, Georgia 30329; phone:
financial disclosure reports at the 404–639–7570; Email: omb@cdc.gov.
beginning of and annually during their Centers for Disease Control and SUPPLEMENTARY INFORMATION: Under the
terms. NIOSH identifies potential Prevention Paperwork Reduction Act of 1995 (PRA)
candidates and provides a slate of [60Day–18–0134; Docket No. CDC–2018– (44 U.S.C. 3501–3520), Federal agencies
nominees for consideration to the 0078] must obtain approval from the Office of
Director of CDC for STAC membership Management and Budget (OMB) for each
each year; CDC reviews the proposed Proposed Data Collection Submitted collection of information they conduct
slate of candidates, and provides a slate for Public Comment and or sponsor. In addition, the PRA also
of nominees for consideration to the Recommendations requires Federal agencies to provide a
Secretary of HHS for final selection. 60-day notice in the Federal Register
HHS notifies selected candidates of AGENCY: Centers for Disease Control and
concerning each proposed collection of
their appointment near the start of the Prevention (CDC), Department of Health
information, including each new
term in October, or as soon as the HHS and Human Services (HHS).
proposed collection, each proposed
selection process is completed. Note ACTION: Notice with comment period. extension of existing collection of
that the need for different expertise information, and each reinstatement of
SUMMARY: The Centers for Disease
varies from year to year and a candidate previously approved information
Control and Prevention (CDC), as part of
who is not selected in one year may be collection before submitting the
its continuing effort to reduce public
reconsidered in a subsequent year. collection to the OMB for approval. To
burden and maximize the utility of
Candidates should submit the government information, invites the comply with this requirement, we are
following items: general public and other Federal publishing this notice of a proposed
D Current curriculum vitae, including agencies the opportunity to comment on data collection as described below.
complete contact information The OMB is particularly interested in
a proposed and/or continuing
(telephone numbers, mailing address, comments that will help:
information collection, as required by 1. Evaluate whether the proposed
email address); the Paperwork Reduction Act of 1995. collection of information is necessary
D The category of membership This notice invites comment on a for the proper performance of the
(environmental medicine or proposed information collection project functions of the agency, including
environmental health specialist, titled Foreign Quarantine Regulations, whether the information will have
occupational physician, pulmonary an information collection related to practical utility;
physician, representative of WTC illness and death reports from airplanes 2. Evaluate the accuracy of the
responders, representative of certified- and maritime vessels coming to the agency’s estimate of the burden of the
eligible WTC survivors, industrial United States, illness and death proposed collection of information,
hygienist, toxicologist, epidemiologist, investigations of travelers, and including the validity of the
or mental health professional) that the information from importers of certain methodology and assumptions used;
candidate is qualified to represent; items specified under 42 CFR 71 3. Enhance the quality, utility, and
D A summary of the background, subpart F. clarity of the information to be
experience, and qualifications that DATES: CDC must receive written collected; and
demonstrates the candidate’s suitability comments on or before November 6, 4. Minimize the burden of the
for the nominated membership category; 2018. collection of information on those who
and ADDRESSES: You may submit comments, are to respond, including through the
D At least one letter of identified by Docket No. CDC–2018– use of appropriate automated,
recommendation from a person(s) not 0078 by any of the following methods: electronic, mechanical, or other
employed by HHS. (Candidates may • Federal eRulemaking Portal: technological collection techniques or
submit letter(s) from current HHS Regulations.gov. Follow the instructions other forms of information technology,
employees if they wish, but at least one for submitting comments. e.g., permitting electronic submissions
letter must be submitted by a person not • Mail: Jeffrey M. Zirger, Information of responses.
Collection Review Office, Centers for 5. Assess information collection costs.
employed by an HHS agency (e.g., CDC,
NIH, FDA, etc.). Disease Control and Prevention, 1600 Proposed Project
Nominations may be submitted by the Clifton Road NE, MS–D74, Atlanta, Foreign Quarantine Regulations (42
candidate him- or herself, or by the Georgia 30329. CFR 71) (OMB Control No. 0920–0134)
person/organization recommending the Instructions: All submissions received (Exp 5/31/2019)—Revision—National
candidate. must include the agency name and Center for Emerging and Zoonotic
Docket Number. CDC will post, without Infectious Diseases (NCEZID), Centers
The Director, Management Analysis
change, all relevant comments to for Disease Control and Prevention
and Services Office, has been delegated
Regulations.gov. (CDC).
the authority to sign Federal Register
Please note: Submit all comments
notices pertaining to announcements of Background and Brief Description
through the Federal eRulemaking portal
meetings and other committee
(regulations.gov) or by U.S. mail to the Section 361 of the Public Health
management activities for both CDC and
address listed above. Service Act (PHSA) (42 U.S.C. 264)
the Agency for Toxic Substances and
daltland on DSKBBV9HB2PROD with NOTICES
Disease Registry. FOR FURTHER INFORMATION CONTACT: To (Attachment A1) authorizes the
request more information on the Secretary of Health and Human Services
Sherri Berger, proposed project or to obtain a copy of to make and enforce regulations
Chief Operating Officer, Centers for Disease the information collection plan and necessary to prevent the introduction,
Control and Prevention. instruments, contact Jeffrey M. Zirger, transmission or spread of communicable
[FR Doc. 2018–19418 Filed 9–6–18; 8:45 am] Information Collection Review Office, diseases from foreign countries into the
BILLING CODE 4163–18–P Centers for Disease Control and United States. Statute and the existing
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![Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45451
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden Total burden
Type of respondent Regulatory provision or form name responses per
respondents per response hours
respondent (in hours)
Importers ................................ 42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates 20 1 1 20
Importer .................................. 42 CFR 71.56 (a)(2) African Rodents—Request for exemption .. 25 1 1 25
Importer .................................. 42 CFR 71.56(a)(iii) Appeal ......................................................... 2 1 1 2
Importer .................................. 42 CFR 71.32 Statements or documentation of non-infectious- 2,000 1 5/60 167
ness.
Total ................................ ....................................................................................................... ........................ ........................ ........................ 268,493
Jeffrey M. Zirger, (c) Enhance the quality, utility, and through this study will be used to
Acting Chief, Information Collection Review clarity of the information to be evaluate whether the TLC intervention
Office, Office of Scientific Integrity, Office collected; is an effective HIV-prevention strategy
of the Associate Director for Science, Office (d) Minimize the burden of the by assessing whether exposure to TLC
of the Director, Centers for Disease Control collection of information on those who services results in improvements in
and Prevention.
are to respond, including, through the participants’ health and HIV prevention
[FR Doc. 2018–19381 Filed 9–6–18; 8:45 am] behaviors. The trial will assess whether
use of appropriate automated,
BILLING CODE 4163–18–P electronic, mechanical, or other intervention participants’ behaviors
technological collection techniques or significantly change from baseline to 4-
other forms of information technology, and 8-month follow-up periods.
DEPARTMENT OF HEALTH AND This study will be carried out in
e.g., permitting electronic submission of
HUMAN SERVICES Chicago, Illinois, where the TLC
responses; and
Centers for Disease Control and (e) Assess information collection program is located. The study
Prevention costs. population will include 150 HIV-
To request additional information on negative adult transgender women
[30Day–18–18CI] the proposed project or to obtain a copy living in the Chicago metropolitan area.
of the information collection plan and Participants will be at least 18 years of
Agency Forms Undergoing Paperwork age; self-identify as transgender,
instruments, call (404) 639–7570 or
Reduction Act Review transsexual, women and/or female who
send an email to omb@cdc.gov. Direct
In accordance with the Paperwork written comments and/or suggestions was assigned male sex at birth; and have
Reduction Act of 1995, the Centers for regarding the items contained in this a self-reported history of sex with men
Disease Control and Prevention (CDC) notice to the Attention: CDC Desk in the past four months. The study
has submitted the information Officer, Office of Management and population will also include 10 TLC
collection request titled ‘‘Evaluation of Budget, 725 17th Street NW, staff members. Staff members will be
TransLife Center (TLC): A Locally- Washington, DC 20503 or by fax to (202) adults, involved in the delivery of TLC
Developed Combination Prevention 395–5806. Provide written comments intervention services. Participation in
Intervention for Transgender Women at within 30 days of notice publication. this study is voluntary.
High Risk of HIV Infection’’ to the Office We anticipate enrollment of a diverse
Proposed Project sample of transgender women
of Management and Budget (OMB) for
review and approval. CDC previously Evaluation of TransLife Center (TLC): comprised mainly of racial/ethnic
published a ‘‘Proposed Data Collection A Locally-Developed Combination minority participants under 35 years of
Submitted for Public Comment and Prevention Intervention for Transgender age, consistent with the current TLC
Recommendations’’ notice on January Women at High Risk of HIV Infection— program and the epidemiology of HIV
30, 2018 to obtain comments from the New—National Center for HIV/AIDS, infection among transgender women.
public and affected agencies. CDC Viral Hepatitis, STD and TB Prevention Intervention participants will be
received one (1) comment related to the (NCHHSTP), Centers for Disease Control recruited to the study through a
previous notice. This notice serves to and Prevention (CDC). combination of approaches, including
allow an additional 30 days for public traditional print advertisement, referral,
Background and Brief Description
and affected agency comments. in-person outreach, and through word of
CDC will accept all comments for this The National Center for HIV/AIDS, mouth. TLC staff members will be
proposed information collection project. Viral Hepatitis, STD and TB Prevention randomly selected to participate in the
The Office of Management and Budget is requesting approval for 24 months of evaluation.
is particularly interested in comments data collection entitled, ‘‘Evaluation of A computer-assisted quantitative
that: TransLife Center (TLC): A Locally- assessment will be used to collect
(a) Evaluate whether the proposed Developed Combination Prevention information for this study, which will
collection of information is necessary Intervention for Transgender Women at be delivered at the time of study
for the proper performance of the High Risk for HIV Infection.’’ The enrollment and again at 4-month and 8-
functions of the agency, including purpose of this study is to evaluate the month follow-ups. The assessment will
daltland on DSKBBV9HB2PROD with NOTICES
whether the information will have efficacy of TLC, which provides be used to measure changes in sexual
practical utility; combination (biomedical, behavioral risk behavior including condom use and
(b) Evaluate the accuracy of the and social/structural) HIV prevention pre-exposure prophylaxis (PrEP) care
agencies estimate of the burden of the and care services to adult transgender engagement. Intervention mediators,
proposed collection of information, women at high risk for HIV infection, in including gender affirmation, collective
including the validity of the a culturally specific and accessible self-esteem and social support, and
methodology and assumptions used; environment. The information collected intervention satisfaction will also be
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Document Created: 2018-09-07 00:15:55
Document Modified: 2018-09-07 00:15:55
| 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 | CDC must receive written comments on or before November 6, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, 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 | 83 FR 45449 |
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