81 FR 46675 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 137 (July 18, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 137 (July 18, 2016)
| Page Range | 46675-46677 | |
| FR Document | 2016-16882 |
[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)] [Notices] [Pages 46675-46677] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16882] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-1011; Docket No. CDC-2016-0061] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a request for extension of an approved information collection entitled Emergency Epidemic [[Page 46676]] Investigation Data Collections (OMB Control No. 0920-1011). CDC will use the information collected to identify prevention and control measures in response to outbreaks and other public health events. DATES: Written comments must be received on or before September 16, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0061 by any of the following methods: Federal eRulemaking Portal: Regulations.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: [email protected]. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start- up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Emergency Epidemic Investigation Data Collections (OMB control number 0920-1011), Expiration 03-31-2017-Extension--Division of Scientific Education and Professional Development, Center for Surveillance, Education, and Laboratory Services, Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC previously conducted Emergency Epidemic Investigations (EEIs) under Office of Management and Budget (OMB) control number 0920-0008. In 2013, CDC received OMB approval (OMB control number 0920-1011) for a new OMB generic clearance for a 3-year period to collect vital information during EEIs in response to urgent outbreaks or events (i.e., natural, biological, chemical, nuclear, radiological) characterized by undetermined agents, undetermined sources, undetermined transmission, or undetermined risk factors. CDC seeks OMB approval for an extension of this generic clearance (OMB control number 0920-1011) for a 3-year period. Supporting effective emergency epidemic investigations is one of the most important ways that CDC protects the health of the public. CDC is frequently called upon to conduct EEIs at the request of local, state, or international health authorities seeking support to respond to urgent outbreaks or urgent public health-related events. In response to external partner requests, CDC provides necessary epidemiologic support to identify the agents, sources, modes of transmission, or risk factors to effectively implement rapid prevention and control measures to protect the public's health. Data collection is a critical component of the epidemiologic support provided by CDC; data are analyzed to determine the agents, sources, modes of transmission, or risk factors so that effective prevention and control measures can be implemented. During an unanticipated outbreak or event, immediate action by CDC is necessary to minimize or prevent public harm. The legal justification for EEIs are found in the Public Health Service Act (42 U.S.C. Sec. 301[241](a). Successful investigations are dependent on rapid and flexible data collection that evolves during the investigation and is customized to the unique circumstances of each outbreak or event. Data collection elements will be those necessary to identify the agents, sources, mode of transmission, or risk factors. Examples of potential data collection methods include telephone or face-to-face interview; email, web or other type of electronic questionnaire; paper-and-pencil questionnaire; focus groups; medical record review; laboratory record review; collection of clinical samples; and environmental assessment. Respondents will vary depending on the nature of the outbreak or event; examples of potential respondents include health care professionals, patients, laboratorians, and the general public. Participation in EEIs is voluntary and there are no anticipated costs to respondents other than their time. CDC will use the information gathered during EEIs to rapidly identify and effectively implement measures to minimize or prevent public harm. CDC projects 60 EEIs in response to outbreaks or events characterized by undetermined agents, undetermined sources, undetermined transmission, or undetermined risk factors annually. The projected average number of respondents is 200 per EEI, for a total of 12,000 respondents. CDC estimates the average burden per response is 0.5 hours and each respondent will be asked to respond once. Therefore, the total estimated annual burden hours are 6,000. These estimates are based on the reported burden for EEIs that have been performed during the previous two years. [[Page 46677]] OMB approval is requested for three years. Participation is based on previous Emergency Epidemic Investigations. There are no costs to respondents. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Total number Average burden Total burden Type of respondent Form name Number of of responses per response hours (in respondents per respondent (in hours) hours) ---------------------------------------------------------------------------------------------------------------- Emergency Epidemic Emergency 12,000 1 30/60 6,000 Investigation Participants. Epidemic Investigation Data Collection Instruments. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 6,000 ---------------------------------------------------------------------------------------------------------------- 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. 2016-16882 Filed 7-15-16; 8:45 am] BILLING CODE 4163-18-P
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ROUTINE USES OF RECORDS MAINTAINED IN THE suspected or confirmed compromise and the requirements of the National
SYSTEM INCLUDING CATEGORIES OF USERS AND there is a risk of harm to economic or Archives and Records Administration.
THE PURPOSES OF SUCH USES: property interests, identity theft or Users may delete their own information
Users interacting with third-party fraud, or harm to the security or from the system at any time.
applications, such as those developed integrity of this system or other systems
by government agencies, may be asked SYSTEM MANAGER AND ADDRESS:
or programs (whether maintained by
to authorize the third-party application GSA or another agency or entity) that Director, USA.gov, General Services
to access their system resources, such as rely upon the compromised Administration, 1800 F Street NW.,
their personal profile information. If a information; and (3) the disclosure Washington, DC 20405.
user authorizes use of his or her made to such agencies, entities, and NOTIFICATION PROCEDURE:
information, the third-party application persons is reasonably necessary to assist
will be given programmatic access to the Individuals or users maintain their
in connection with GSA’s efforts to own information. Inquires can be made
user’s account resources. All respond to the suspected or confirmed
interactions with a user’s account, such via the Web site at https://www.usa.gov,
compromise and prevent, minimize, or or at the above address under ‘System
as reading personal profile information, remedy such harm.
are logged and are auditable by the user. Manager and Address’.
Users can revoke a third-party POLICIES AND PRACTICES FOR STORING,
RECORD ACCESS PROCEDURES:
application’s authorization to access RETRIEVING, ACCESSING, RETAINING AND
DISPOSING OF RECORDS IN THE SYTEM: Individuals or users wishing to access
their account resources at any time. their own records may do so by
System information may be accessed by STORAGE: password.
system managers, technical support and All records are stored electronically in
designated analysts in the course of CONTESTING RECORD PROCEDURES:
a database. Personally identifiable
their official duties. Information from information is encrypted. Individuals or users of the system
this system also may be disclosed as a may amend or delete their own records
routine use: RETRIEVABILITY: online.
a. In any legal proceeding, where Records are retrieved using an
RECORD SOURCE CATEGORIES:
pertinent, to which GSA, a GSA authorization protocol. A user of the
employee, or the United States is a party system grants explicit authorization to The sources for information in the
before a court or administrative body. an application or government agency to system are the individuals (or system
b. To a Federal, State, local, or foreign access his or her profile. The system users) for whom the records are
agency responsible for investigating, generates a unique token that authorizes maintained and third-party applications
prosecuting, enforcing, or carrying out a only that application or agency to access which the user has authorized to
statute, rule, regulation, or order when the user’s account. The system contribute information to his or her
GSA becomes aware of a violation or correlates the unique token, ensures that account.
potential violation of civil or criminal both the agency and the user involved [FR Doc. 2016–16868 Filed 7–15–16; 8:45 am]
law or regulation. are correct, and returns the information BILLING CODE 6820–34–P
c. To a Member of Congress or his or to the agency.
her staff on behalf of, and at the request
of, the individual who is the subject of SAFEGUARDS:
DEPARTMENT OF HEALTH AND
the record. System records are safeguarded in HUMAN SERVICES
d. To the Office of Personnel accordance with the requirements of the
Management (OPM), the Office of Privacy Act. Access to physical Centers for Disease Control and
Management and Budget (OMB), and infrastructure is limited to authorized Prevention
the Government Accountability Office individuals with passwords; the
(GAO) in accordance with their [60Day–16–1011; Docket No. CDC–2016–
database is maintained behind a firewall 0061]
responsibilities for evaluating Federal certified in accordance with National
programs. Institute of Standards and Technology Proposed Data Collection Submitted
e. To an expert, consultant, or standards and information in the for Public Comment and
contractor of GSA in the performance of database is encrypted. Recommendations
a Federal duty to which the information
is relevant. SAFEGUARDS AGAINIST UNAUTHORIZED ACCESS: AGENCY: Centers for Disease Control and
f. To the National Archives and Records are safeguarded in Prevention (CDC), Department of Health
Records Administration (NARA) for accordance with Privacy Act and Human Services (HHS).
records management purposes. requirements. Access is limited to ACTION: Notice with comment period.
g. To a Federal agency in connection authorized individuals and protected
with the hiring or retention of an with two-factor authentication, SUMMARY: The Centers for Disease
employee; the issuance of a security databases are behind a firewall. Control and Prevention (CDC), as part of
clearance; the reporting of an Personally Identifiable Information is its continuing efforts to reduce public
investigation; the letting of a contract; or encrypted at rest, and all transmissions burden and maximize the utility of
the issuance of a grant, license, or other of any information over external government information, invites the
benefit to the extent that the information general public and other Federal
asabaliauskas on DSK3SPTVN1PROD with NOTICES
networks are encrypted. All passwords,
is relevant and necessary to a decision. encryption algorithms and firewalls are agencies to take this opportunity to
h. To appropriate agencies, entities, compliant with National Institute of comment on proposed and/or
and persons when (1) the Agency Standards and Technology standards. continuing information collections, as
suspects or has confirmed that the required by the Paperwork Reduction
security or confidentiality of RETENTION AND DISPOSAL: Act of 1995. This notice invites
information in the system of records has System records are retained and comment on a request for extension of
been compromised; (2) The Agency has disposed of according to GSA records an approved information collection
determined that as a result of the maintenance and disposition schedules entitled Emergency Epidemic
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.
Docket Number. All relevant comments collecting, validating and verifying
received will be posted without change Successful investigations are
information, processing and dependent on rapid and flexible data
to Regulations.gov, including any maintaining information, and disclosing
personal information provided. For collection that evolves during the
and providing information; to train investigation and is customized to the
access to the docket to read background personnel and to be able to respond to
documents or comments received, go to unique circumstances of each outbreak
a collection of information, to search or event. Data collection elements will
Regulations.gov. data sources, to complete and review be those necessary to identify the
Please note: All public comment should be the collection of information; and to agents, sources, mode of transmission,
submitted through the Federal eRulemaking transmit or otherwise disclose the or risk factors. Examples of potential
portal (Regulations.gov) or by U.S. mail to the information.
address listed above. data collection methods include
Proposed Project telephone or face-to-face interview;
FOR FURTHER INFORMATION CONTACT: To Emergency Epidemic Investigation email, web or other type of electronic
request more information on the Data Collections (OMB control number questionnaire; paper-and-pencil
proposed project or to obtain a copy of 0920–1011), Expiration 03–31–2017– questionnaire; focus groups; medical
the information collection plan and Extension—Division of Scientific record review; laboratory record review;
instruments, contact the Information Education and Professional collection of clinical samples; and
Collection Review Office, Centers for Development, Center for Surveillance, environmental assessment. Respondents
Disease Control and Prevention, 1600 Education, and Laboratory Services, will vary depending on the nature of the
Clifton Road NE., MS–D74, Atlanta, Centers for Disease Control and outbreak or event; examples of potential
Georgia 30329; phone: 404–639–7570; Prevention (CDC). respondents include health care
Email: omb@cdc.gov. professionals, patients, laboratorians,
SUPPLEMENTARY INFORMATION: Under the Background and Brief Description and the general public. Participation in
Paperwork Reduction Act of 1995 (PRA) CDC previously conducted Emergency EEIs is voluntary and there are no
(44 U.S.C. 3501–3520), Federal agencies Epidemic Investigations (EEIs) under anticipated costs to respondents other
must obtain approval from the Office of Office of Management and Budget than their time. CDC will use the
Management and Budget (OMB) for each (OMB) control number 0920–0008. In information gathered during EEIs to
collection of information they conduct 2013, CDC received OMB approval rapidly identify and effectively
or sponsor. In addition, the PRA also (OMB control number 0920–1011) for a implement measures to minimize or
requires Federal agencies to provide a new OMB generic clearance for a 3-year prevent public harm.
60-day notice in the Federal Register period to collect vital information CDC projects 60 EEIs in response to
concerning each proposed collection of during EEIs in response to urgent outbreaks or events characterized by
information, including each new outbreaks or events (i.e., natural, undetermined agents, undetermined
proposed collection, each proposed biological, chemical, nuclear, sources, undetermined transmission, or
extension of existing collection of radiological) characterized by undetermined risk factors annually. The
information, and each reinstatement of undetermined agents, undetermined projected average number of
previously approved information sources, undetermined transmission, or respondents is 200 per EEI, for a total
collection before submitting the undetermined risk factors. CDC seeks of 12,000 respondents. CDC estimates
asabaliauskas on DSK3SPTVN1PROD with NOTICES
collection to OMB for approval. To OMB approval for an extension of this the average burden per response is 0.5
comply with this requirement, we are generic clearance (OMB control number hours and each respondent will be
publishing this notice of a proposed 0920–1011) for a 3-year period. asked to respond once. Therefore, the
data collection as described below. Supporting effective emergency total estimated annual burden hours are
Comments are invited on: (a) Whether epidemic investigations is one of the 6,000. These estimates are based on the
the proposed collection of information most important ways that CDC protects reported burden for EEIs that have been
is necessary for the proper performance the health of the public. CDC is performed during the previous two
of the functions of the agency, including frequently called upon to conduct EEIs years.
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OMB approval is requested for three Emergency Epidemic Investigations.
years. Participation is based on previous There are no costs to respondents.
ESTIMATED ANNUALIZED BURDEN HOURS
Total Average Total burden
Number of number of burden per
Type of respondent Form name hours
respondents responses per response (in hours)
respondent (in hours)
Emergency Epidemic Investigation Emergency Epidemic Investigation 12,000 1 30/60 6,000
Participants. Data Collection Instruments.
Total ........................................... ........................................................... ........................ ........................ ........................ 6,000
Jeffrey M. Zirger, regulations for select agents and toxins, DEPARTMENT OF HEALTH AND
Acting Chief, Information Collection Review and the safe possession, use and transfer HUMAN SERVICES
Office, Office of Scientific Integrity, Office of select agents and toxins; and (6) leads
of the Associate Director for Science, Office responses to laboratory incidents and Centers for Disease Control and
of the Director, Centers for Disease Control Prevention
and Prevention.
emergencies.
[FR Doc. 2016–16882 Filed 7–15–16; 8:45 am] Office of Laboratory Science (CACB). [30-Day–16–16AVB]
BILLING CODE 4163–18–P (1) Provides high-level oversight and
Agency Forms Undergoing Paperwork
coordination of laboratory quality and
Reduction Act Review
safety training programs at all CDC
DEPARTMENT OF HEALTH AND campuses; (2) develops agency-level The Centers for Disease Control and
HUMAN SERVICES plans, policies, procedures and Prevention (CDC) has submitted the
guidelines for implementation of quality following information collection request
Centers for Disease Control and management programs within Centers, to the Office of Management and Budget
Prevention Institute, and Offices (CIOs); (3) assures (OMB) for review and approval in
regulatory compliance and tracking for accordance with the Paperwork
Statement of Organization, Functions, Reduction Act of 1995. The notice for
and Delegations of Authority CDC’s portfolio of laboratory developed
tests; and (4) provides oversight of the the proposed information collection is
Part C (Centers for Disease Control catalog of laboratory safety training published to obtain comments from the
and Prevention) of the Statement of activities and tracking agency-wide public and affected agencies.
Organization, Functions, and Written comments and suggestions
progress and compliance with
Delegations of Authority of the from the public and affected agencies
laboratory safety training requirements. concerning the proposed collection of
Department of Health and Human
Services (45 FR 67772–76, dated Office of Laboratory Safety (CACC). information are encouraged. Your
October 14, 1980, and corrected at 45 FR (1) Provides high-level oversight and comments should address any of the
69296, October 20, 1980, as amended coordination of laboratory safety at all following: (a) Evaluate whether the
most recently at 81 FR 30307–30308, CDC campuses; (2) develops and assures proposed collection of information is
dated May 16, 2016) is amended to effectiveness of agency-level plans, necessary for the proper performance of
reflect the reorganization of the Office of policies, manuals and tools for the functions of the agency, including
the Director, Centers for Disease Control implementation of laboratory safety whether the information will have
and Prevention. standards; (3) assures regulatory practical utility; (b) Evaluate the
Section C–B, Organization and compliance for biological safety, accuracy of the agencies estimate of the
Functions, is hereby amended as chemical safety, radiation safety and the burden of the proposed collection of
follows: possession, use and transport of select information, including the validity of
After the title and the mission and agents and toxins; and (4) provides the methodology and assumptions used;
function statements for the Office of the expertise and consultation for biological (c) Enhance the quality, utility, and
Associate Director for Laboratory safety, chemical safety and radiation clarity of the information to be
Science and Safety (CAC) insert the collected; (d) Minimize the burden of
safety.
following: the collection of information on those
Office of the Director (CAC1). (1) Sherri Berger, who are to respond, including through
Provides scientific, technical, and Chief Operating Officer, Centers for Disease the use of appropriate automated,
managerial expertise and leadership in Control and Prevention. electronic, mechanical, or other
the development and enhancement of [FR Doc. 2016–16884 Filed 7–15–16; 8:45 am] technological collection techniques or
laboratory science and safety programs; other forms of information technology,
BILLING CODE 4160–18–P
(2) oversees and monitors the e.g., permitting electronic submission of
development, implementation, and responses; and (e) Assess information
asabaliauskas on DSK3SPTVN1PROD with NOTICES
evaluation of the laboratory safety and collection costs.
quality management programs across To request additional information on
CDC; (3) advises on policy, the proposed project or to obtain a copy
partnerships, and issues management of the information collection plan and
matters; (4) advises on matters related to instruments, call (404) 639–7570 or
internal and external public health send an email to omb@cdc.gov. Written
communications; (5) provides oversight comments and/or suggestions regarding
to ensure CDC compliance with the items contained in this notice
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Document Created: 2016-07-16 02:28:14
Document Modified: 2016-07-16 02:28:14
| 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 September 16, 2016. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 81 FR 46675 |
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