81 FR 3138 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 12 (January 20, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 12 (January 20, 2016)
| Page Range | 3138-3139 | |
| FR Document | 2016-00955 |
[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)] [Notices] [Pages 3138-3139] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00955] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0850] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Background and Brief Description Laboratory Response Network, (OMB Control Number 0920-0850, expires April 30, 2016)--Extension--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Laboratory Response Network (LRN) was established by the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to Federal departments and agencies. The LRN's mission is to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological threats and other public health emergencies. When Federal, State and local public health laboratories voluntarily join the LRN, they assume specific responsibilities and are required to provide information to the LRN Program Office at CDC. Each laboratory must submit and maintain complete information regarding the testing capabilities of the laboratory. Biennially, laboratories are required to review, verify and update their testing capability information. Complete testing capability information is required in order for the LRN Program Office to determine the ability of the Network to respond to a biological or chemical threat event. The sensitivity of all information associated with the LRN requires the LRN Program Office to obtain personal information about all individuals accessing the LRN Web site. In addition, the LRN Program Office must be able to contact all laboratory personnel during an event so each laboratory staff member that obtains access to the restricted LRN Web site must provide his or her contact information to the LRN Program Office. As a requirement of membership, LRN Laboratories must report all biological and chemical testing results to the LRN Program at CDC using a CDC developed software tool called the LRN Results Messenger. This information is essential for surveillance of anomalies, to support response to an event that may involve multiple agencies and to manage limited resources. LRN Laboratories must also participate in and report results for Proficiency Testing Challenges or Validation Studies. LRN Laboratories participate in multiple Proficiency Testing Challenges, Exercises and/or Validation Studies every year consisting of five to 500 simulated samples provided by the LRN Program Office. It is necessary to conduct such challenges in order to verify the testing capability of the LRN Laboratories. The rarity of biological or chemical agents perceived to be of bioterrorism concern prevents some LRN Laboratories from maintaining proficiency as a result of day-to-day testing. Simulated samples are therefore distributed to ensure proficiency across the LRN. The results obtained from testing these simulated samples must also be entered into Results Messenger for evaluation by the LRN Program Office. During a surge event resulting from a bioterrorism or chemical terrorism attack, LRN Laboratories are also required to submit all testing results using LRN Results Messenger. The LRN Program Office requires these results in order to track the progression of a bioterrorism event and respond in the most efficient and effective way possible and for data sharing with other Federal partners involved in the response. The number of samples tested during a response to a possible event could range from 10,000 to more than 500,000 samples depending on the length and breadth of the event. Since there is potentially a large range in the number of samples for a surge event, CDC estimates the annualized burden for this event will be 2,250,000 hours or 625 responses per respondent. The requalification occurred between October 24, 2014 and November 7, 2014. We had 122 domestic LRN labs tasked with completing the requalification. We had a 90% response rate. We conducted LRN proficiency testing (PT). The purpose of PT is to simulate real samples for labs that would not have regularly performed some of the LRN procedures. Having the ability to conduct LRN PTs under OMB approval has led to improved laboratory performance and better preparedness. In FY13, the PT passing rate was 89%, which improved to 96% in FY14 and 97% in FY15. There is no cost to the respondents other than their time. The total estimated annualized burden is 2,382,300 hours. [[Page 3139]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (hours) ---------------------------------------------------------------------------------------------------------------- Public Health Laboratories....... Biennial 150 1 2 Requalification. Public Health Laboratories....... General Surveillance 150 25 24 Testing Results. Public Health Laboratories....... Proficiency Testing/ 150 5 56 Validation Testing Results. Public Health Laboratories....... Surge Event Testing 150 625 24 Results. ---------------------------------------------------------------------------------------------------------------- Leroy A. Richardson, 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. 2016-00955 Filed 1-19-16; 8:45 am] BILLING CODE 4163-18-P
![3138 Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Notices
Leroy A. Richardson, by fax to (202) 395–5806. Written response to an event that may involve
Chief, Information Collection Review Office, comments should be received within 30 multiple agencies and to manage limited
Office of Scientific Integrity, Office of the days of this notice. resources. LRN Laboratories must also
Associate Director for Science, Office of the participate in and report results for
Director, Centers for Disease Control and Proposed Project
Proficiency Testing Challenges or
Prevention. Background and Brief Description Validation Studies. LRN Laboratories
[FR Doc. 2016–00940 Filed 1–19–16; 8:45 am] participate in multiple Proficiency
Laboratory Response Network, (OMB
BILLING CODE 4163–18–P
Control Number 0920–0850, expires Testing Challenges, Exercises and/or
April 30, 2016)—Extension—National Validation Studies every year consisting
Center for Emerging and Zoonotic of five to 500 simulated samples
DEPARTMENT OF HEALTH AND provided by the LRN Program Office. It
HUMAN SERVICES Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention is necessary to conduct such challenges
Centers for Disease Control and (CDC). in order to verify the testing capability
Prevention of the LRN Laboratories. The rarity of
Background and Brief Description biological or chemical agents perceived
[30Day–16–0850] The Laboratory Response Network to be of bioterrorism concern prevents
(LRN) was established by the some LRN Laboratories from
Agency Forms Undergoing Paperwork maintaining proficiency as a result of
Reduction Act Review Department of Health and Human
Services (HHS), Centers for Disease day-to-day testing. Simulated samples
The Centers for Disease Control and Control and Prevention (CDC) in are therefore distributed to ensure
Prevention (CDC) has submitted the accordance with Presidential Decision proficiency across the LRN. The results
following information collection request Directive 39, which outlined national obtained from testing these simulated
to the Office of Management and Budget anti-terrorism policies and assigned samples must also be entered into
(OMB) for review and approval in specific missions to Federal Results Messenger for evaluation by the
accordance with the Paperwork departments and agencies. The LRN’s LRN Program Office.
Reduction Act of 1995. The notice for mission is to maintain an integrated During a surge event resulting from a
the proposed information collection is national and international network of bioterrorism or chemical terrorism
published to obtain comments from the laboratories that can respond to attack, LRN Laboratories are also
public and affected agencies. suspected acts of biological, chemical, required to submit all testing results
Written comments and suggestions or radiological threats and other public using LRN Results Messenger. The LRN
from the public and affected agencies health emergencies. Program Office requires these results in
concerning the proposed collection of When Federal, State and local public order to track the progression of a
information are encouraged. Your health laboratories voluntarily join the bioterrorism event and respond in the
comments should address any of the LRN, they assume specific most efficient and effective way possible
following: (a) Evaluate whether the responsibilities and are required to and for data sharing with other Federal
proposed collection of information is provide information to the LRN Program partners involved in the response. The
necessary for the proper performance of Office at CDC. Each laboratory must number of samples tested during a
the functions of the agency, including submit and maintain complete response to a possible event could range
whether the information will have information regarding the testing from 10,000 to more than 500,000
practical utility; (b) Evaluate the capabilities of the laboratory. samples depending on the length and
accuracy of the agencies estimate of the Biennially, laboratories are required to breadth of the event. Since there is
burden of the proposed collection of review, verify and update their testing potentially a large range in the number
information, including the validity of capability information. Complete testing of samples for a surge event, CDC
the methodology and assumptions used; capability information is required in estimates the annualized burden for this
(c) Enhance the quality, utility, and order for the LRN Program Office to event will be 2,250,000 hours or 625
clarity of the information to be determine the ability of the Network to responses per respondent.
collected; (d) Minimize the burden of respond to a biological or chemical The requalification occurred between
the collection of information on those threat event. The sensitivity of all October 24, 2014 and November 7, 2014.
who are to respond, including through information associated with the LRN We had 122 domestic LRN labs tasked
the use of appropriate automated, requires the LRN Program Office to with completing the requalification. We
electronic, mechanical, or other obtain personal information about all had a 90% response rate.
technological collection techniques or individuals accessing the LRN Web site. We conducted LRN proficiency
other forms of information technology, In addition, the LRN Program Office testing (PT). The purpose of PT is to
e.g., permitting electronic submission of must be able to contact all laboratory simulate real samples for labs that
responses; and (e) Assess information personnel during an event so each would not have regularly performed
collection costs. laboratory staff member that obtains some of the LRN procedures. Having the
To request additional information on access to the restricted LRN Web site ability to conduct LRN PTs under OMB
the proposed project or to obtain a copy must provide his or her contact approval has led to improved laboratory
of the information collection plan and information to the LRN Program Office. performance and better preparedness. In
instruments, call (404) 639–7570 or As a requirement of membership, LRN FY13, the PT passing rate was 89%,
send an email to omb@cdc.gov. Written Laboratories must report all biological which improved to 96% in FY14 and
tkelley on DSK4VPTVN1PROD with NOTICES
comments and/or suggestions regarding and chemical testing results to the LRN 97% in FY15.
the items contained in this notice Program at CDC using a CDC developed There is no cost to the respondents
should be directed to the Attention: software tool called the LRN Results other than their time. The total
CDC Desk Officer, Office of Management Messenger. This information is essential estimated annualized burden is
and Budget, Washington, DC 20503 or for surveillance of anomalies, to support 2,382,300 hours.
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![Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Notices 3139
ESTIMATED ANNUALIZED BURDEN HOURS
Average number Average burden
Number of
Type of respondents Form name of responses per per response
respondents respondent (hours)
Public Health Laboratories ..................... Biennial Requalification ......................... 150 1 2
Public Health Laboratories ..................... General Surveillance Testing Results ... 150 25 24
Public Health Laboratories ..................... Proficiency Testing/Validation Testing 150 5 56
Results.
Public Health Laboratories ..................... Surge Event Testing Results ................ 150 625 24
Leroy A. Richardson, Prevention, 1600 Clifton Road NE., MS– burden of the collection of information
Chief, Information Collection Review Office, D74, Atlanta, Georgia 30329. on respondents, including through the
Office of Scientific Integrity, Office of the Instructions: All submissions received use of automated collection techniques
Associate Director for Science, Office of the must include the agency name and or other forms of information
Director, Centers for Disease Control and Docket Number. All relevant comments technology; and (e) estimates of capital
Prevention. received will be posted without change or start-up costs and costs of operation,
[FR Doc. 2016–00955 Filed 1–19–16; 8:45 am] to Regulations.gov, including any maintenance, and purchase of services
BILLING CODE 4163–18–P personal information provided. For to provide information. Burden means
access to the docket to read background the total time, effort, or financial
documents or comments received, go to resources expended by persons to
DEPARTMENT OF HEALTH AND Regulations.gov. generate, maintain, retain, disclose or
HUMAN SERVICES provide information to or for a Federal
Please note: All public comment should be
Centers for Disease Control and submitted through the Federal eRulemaking agency. This includes the time needed
portal (Regulations.gov) or by U.S. mail to the to review instructions; to develop,
Prevention address listed above. acquire, install and utilize technology
[60Day–16–1074; Docket No. CDC–2016– and systems for the purpose of
0006] FOR FURTHER INFORMATION CONTACT: To
request more information on the collecting, validating and verifying
Proposed Data Collection Submitted proposed project or to obtain a copy of information, processing and
for Public Comment and the information collection plan and maintaining information, and disclosing
Recommendations instruments, contact the Information and providing information; to train
Collection Review Office, Centers for personnel and to be able to respond to
AGENCY: Centers for Disease Control and Disease Control and Prevention, 1600 a collection of information, to search
Prevention (CDC), Department of Health Clifton Road NE., MS–D74, Atlanta, data sources, to complete and review
and Human Services (HHS). Georgia 30329; phone: 404–639–7570; the collection of information; and to
ACTION: Notice with comment period. Email: omb@cdc.gov. transmit or otherwise disclose the
SUPPLEMENTARY INFORMATION: Under the information.
SUMMARY: The Centers for Disease
Control and Prevention (CDC), as part of Paperwork Reduction Act of 1995 (PRA) Proposed Project
its continuing efforts to reduce public (44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of Colorectal Cancer Control Program
burden and maximize the utility of (CRCCP) Monitoring Activities—(OMB
government information, invites the Management and Budget (OMB) for each
collection of information they conduct No. 0920–1074, exp. 12/31/2015)—
general public and other Federal Reinstatement with Change—National
or sponsor. In addition, the PRA also
agencies to take this opportunity to Center for Chronic Disease Prevention
requires Federal agencies to provide a
comment on proposed and/or and Health Promotion (NCCDPHP),
60-day notice in the Federal Register
continuing information collections, as Centers for Disease Control and
concerning each proposed collection of
required by the Paperwork Reduction Prevention (CDC).
information, including each new
Act of 1995. This notice invites
proposed collection, each proposed Background and Brief Description
comment on the information collection
extension of existing collection of
project entitled ‘‘Colorectal Cancer CDC is requesting a reinstatement
information, and each reinstatement of
Control Program CRCCP) Monitoring with change of the information
previously approved information
Activities’’. CDC is requesting a collection with the OMB Control
collection before submitting the
reinstatement with change of OMB No. collection to OMB for approval. To number 0920–1074, formerly entitled
0920–1074 to include a redesigned comply with this requirement, we are ‘‘Annual Survey of Colorectal Cancer
survey and a new clinic-level data publishing this notice of a proposed Control Activities Conducted by States
collection. data collection as described below. and Tribal Organizations.’’ In the
DATES: Written comments must be Comments are invited on: (a) Whether previous OMB approval period,
received on or before March 21, 2016. the proposed collection of information information collection consisted of an
ADDRESSES: You may submit comments, is necessary for the proper performance annual grantee survey. In the next OMB
identified by Docket No. CDC–2016– of the functions of the agency, including approval period, information collection
tkelley on DSK4VPTVN1PROD with NOTICES
0006 by any of the following methods: whether the information shall have will consist of a redesigned survey and
Federal eRulemaking Portal: practical utility; (b) the accuracy of the a new clinic-level data collection. The
Regulation.gov. Follow the instructions agency’s estimate of the burden of the number of respondents will increase
for submitting comments. proposed collection of information; (c) and the total estimated annualized
Mail: Leroy A. Richardson, ways to enhance the quality, utility, and burden will increase.
Information Collection Review Office, clarity of the information to be Among cancers that affect both men
Centers for Disease Control and collected; (d) ways to minimize the and women, colorectal cancer (CRC) is
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Document Created: 2016-01-19 23:44:03
Document Modified: 2016-01-19 23:44:03
| 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 | 81 FR 3138 |
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