80_FR_55810 80 FR 55631 - Agency Forms Undergoing Paperwork Reduction Act Review

80 FR 55631 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 179 (September 16, 2015)

Page Range55631-55632
FR Document2015-23226

Federal Register, Volume 80 Issue 179 (Wednesday, September 16, 2015) 
[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55631-55632]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23226]



[[Page 55631]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-15-15AIS]


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 omb@cdc.gov. 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

    CDC Burden of Canine Brucellosis Information Collection--New--
National Center for Emerging and Zoonotic Infectious Diseases, Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Canine brucellosis is a bacterial infection caused by the organism 
Brucella canis. Few seroprevalence studies have been done to estimate 
the prevalence of canine brucellosis, most of which were conducted over 
25 years ago. Two recent reports from Oklahoma and Wisconsin describe 
increasing prevalence in dogs; however, the national burden is not 
known. B. canis is also pathogenic to humans, although human infections 
are thought to be rare in the United States.
    Unlike Brucella abortus, B. melitensis, and B. suis, B. canis is 
not classified as a select agent. As a result, laboratory 
identification of the organism in humans does not require reporting to 
the Laboratory Response Network. Brucella species-specific data are not 
collected in the Nationally Notifiable Disease Surveillance System at 
CDC, and there are no validated Brucella canis serological tests to 
diagnose disease in humans. For these reasons, there are no national 
estimates of B. canis prevalence in humans or canines.
    Additionally, canine infections with other Brucella species have 
been reported in the literature. Zoonotic transmission is a concern 
with all Brucella species pathogenic to humans, and at least one human 
infection with B. suis related to canine contact has been reported. 
Neither the prevalence of canine brucellosis nor the potential risk of 
zoonotic spread to humans is known.
    There has been interest in human brucellosis caused by B. canis 
among the public health community. However, the degree of public health 
importance of human B. canis infections has not yet been ascertained. 
The Council of State and Territorial Epidemiologists approved a 
position statement in 2012 that recommends increased focus on B. canis, 
and urges CDC to support the development of a human diagnostic assay.
    The purpose of this information collection request is to estimate 
the burden of canine brucellosis in the United States, which will aid 
in the determination of the level of public health importance of human 
B. canis infections, and the potential for transmission of brucellosis 
from dogs. An estimate of disease burden in dogs will provide an idea 
of potential transmission between dogs and humans, and determine the 
need for future human public health studies, which is critical during 
this time of scarce resources.
    Veterinary diagnostic laboratories throughout the United States 
will be solicited to provide information on the quantity of test 
requests and positive results for Brucella spp. in canines, outsourcing 
of clinical testing, state-wide policies for reporting of positive 
results, and policies for human exposure to clinical specimens or 
isolates.
    The laboratories were identified through multiple sources: A review 
of the Animal and Plant Health Inspection Service-approved Brucella 
diagnostic laboratories, the National Animal Health Laboratory Network 
laboratories, the American Association of Veterinary Laboratory 
Diagnosticians (AAVLD), and an internet search.
    The outcomes of this information collection are to assess the 
burden of disease in the animal host (dogs, in this case), as well as 
evaluate the knowledge and practices of occupational exposures to the 
organism. The information collected will be used to guide a longer term 
strategy for identification of human cases, understanding risk factors 
and activities associated with zoonotic transmission, and eventually 
validation of a human diagnostic assay. These strategies will be 
implemented using other mechanisms.
    The total annual burden is 139 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Veterinary diagnostic laboratory staff  Burden of Canine                     119               1               1
                                         Brucellosis Information
                                         Collection.
Non-responders (over estimation)......  Telephone script........             119               1            5/60

[[Page 55632]]

 
Other laboratories....................  Burden of Canine                      10               1               1
                                         Brucellosis Information
                                         Collection.
                                                                 -----------------------------------------------
    Total
----------------------------------------------------------------------------------------------------------------


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. 2015-23226 Filed 9-15-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices 55631 DEPARTMENT OF HEALTH AND and Budget, Washington, DC 20503 or and Territorial Epidemiologists HUMAN SERVICES by fax to (202) 395–5806. Written approved a position statement in 2012 comments should be received within 30 that recommends increased focus on B. Centers for Disease Control and days of this notice. canis, and urges CDC to support the Prevention development of a human diagnostic Proposed Project [30 Day–15–15AIS] assay. CDC Burden of Canine Brucellosis The purpose of this information Agency Forms Undergoing Paperwork Information Collection—New—National collection request is to estimate the Reduction Act Review Center for Emerging and Zoonotic burden of canine brucellosis in the Infectious Diseases, Centers for Disease United States, which will aid in the The Centers for Disease Control and Control and Prevention (CDC). determination of the level of public Prevention (CDC) has submitted the Background and Brief Description health importance of human B. canis following information collection request infections, and the potential for to the Office of Management and Budget Canine brucellosis is a bacterial transmission of brucellosis from dogs. (OMB) for review and approval in infection caused by the organism An estimate of disease burden in dogs accordance with the Paperwork Brucella canis. Few seroprevalence will provide an idea of potential Reduction Act of 1995. The notice for studies have been done to estimate the transmission between dogs and humans, the proposed information collection is prevalence of canine brucellosis, most and determine the need for future published to obtain comments from the of which were conducted over 25 years human public health studies, which is public and affected agencies. ago. Two recent reports from Oklahoma Written comments and suggestions critical during this time of scarce and Wisconsin describe increasing resources. from the public and affected agencies prevalence in dogs; however, the concerning the proposed collection of Veterinary diagnostic laboratories national burden is not known. B. canis information are encouraged. Your throughout the United States will be is also pathogenic to humans, although comments should address any of the solicited to provide information on the human infections are thought to be rare following: (a) Evaluate whether the quantity of test requests and positive in the United States. proposed collection of information is Unlike Brucella abortus, B. melitensis, results for Brucella spp. in canines, necessary for the proper performance of and B. suis, B. canis is not classified as outsourcing of clinical testing, state- the functions of the agency, including a select agent. As a result, laboratory wide policies for reporting of positive whether the information will have identification of the organism in results, and policies for human practical utility; (b) Evaluate the humans does not require reporting to exposure to clinical specimens or accuracy of the agencies estimate of the the Laboratory Response Network. isolates. burden of the proposed collection of Brucella species-specific data are not The laboratories were identified information, including the validity of collected in the Nationally Notifiable through multiple sources: A review of the methodology and assumptions used; Disease Surveillance System at CDC, the Animal and Plant Health Inspection (c) Enhance the quality, utility, and and there are no validated Brucella Service-approved Brucella diagnostic clarity of the information to be canis serological tests to diagnose laboratories, the National Animal Health collected; (d) Minimize the burden of disease in humans. For these reasons, Laboratory Network laboratories, the the collection of information on those there are no national estimates of B. American Association of Veterinary who are to respond, including through canis prevalence in humans or canines. Laboratory Diagnosticians (AAVLD), the use of appropriate automated, Additionally, canine infections with and an internet search. electronic, mechanical, or other other Brucella species have been The outcomes of this information technological collection techniques or reported in the literature. Zoonotic collection are to assess the burden of other forms of information technology, transmission is a concern with all disease in the animal host (dogs, in this e.g., permitting electronic submission of Brucella species pathogenic to humans, case), as well as evaluate the knowledge responses; and (e) Assess information and at least one human infection with and practices of occupational exposures collection costs. B. suis related to canine contact has to the organism. The information To request additional information on been reported. Neither the prevalence of collected will be used to guide a longer the proposed project or to obtain a copy canine brucellosis nor the potential risk term strategy for identification of human of the information collection plan and of zoonotic spread to humans is known. cases, understanding risk factors and instruments, call (404) 639–7570 or There has been interest in human activities associated with zoonotic send an email to omb@cdc.gov. Written brucellosis caused by B. canis among transmission, and eventually validation comments and/or suggestions regarding the public health community. However, of a human diagnostic assay. These the items contained in this notice the degree of public health importance strategies will be implemented using should be directed to the Attention: of human B. canis infections has not yet other mechanisms. CDC Desk Officer, Office of Management been ascertained. The Council of State The total annual burden is 139 hours. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per asabaliauskas on DSK7TPTVN1PROD with NOTICES Type of respondents Form name responses per respondents response respondent (in hrs.) Veterinary diagnostic laboratory staff ............. Burden of Canine Brucellosis Information 119 1 1 Collection. Non-responders (over estimation) .................. Telephone script ............................................. 119 1 5/60 VerDate Sep<11>2014 18:18 Sep 15, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1

55632 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (in hrs.) Other laboratories ........................................... Burden of Canine Brucellosis Information 10 1 1 Collection. Total Leroy A. Richardson, Corrective Action Documentation are subject to a penalty are allowed to Chief, Information Collection Review Office, Process. provide reasonable cause justifications Office of Scientific Integrity, Office of the as to why a penalty should not be Associate Director for Science, Office of the OMB No.: 0970–0215. imposed or may develop and implement Director, Centers for Disease Control and Description: 42 U.S.C. 612 (Section corrective compliance procedures to Prevention. 412 of the Social Security Act as [FR Doc. 2015–23226 Filed 9–15–15; 8:45 am] amended by Public Law 104–193, the eliminate the source of the penalty. Personal Responsibility and Work Finally, there is an annual report, which BILLING CODE 4163–18–P Opportunity Reconciliation Act of 1996 requires the Tribes to describe program (PRWORA)), mandates that federally characteristics. All of the above DEPARTMENT OF HEALTH AND recognized Indian Tribes with an requirements are currently approved by HUMAN SERVICES approved Tribal TANF program collect OMB and the Administration for and submit to the Secretary of the Children and Families is simply Administration for Children and Department of Health and Human proposing to extend them without any Families Services data on the recipients served changes. by the Tribes’ programs. This Respondents: Indian Tribes. Submission for OMB Review; information includes both aggregated Comment Request and disaggregated data on case Title: Tribal TANF Data Report, TANF characteristics and individual Annual Report, and Reasonable Cause/ characteristics. In addition, Tribes that 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 ........................................................................ 70 4 451 126,280 Tribal TANF Annual Report ............................................................................. 70 1 40 2,800 Tribal TANF Reasonable Cause/Corrective .................................................... 70 1 60 4,200 Estimated Total Annual Burden Office of Management and Budget, SUMMARY: The U.S. Food and Drug Hours: 133,280. Paperwork Reduction Project, Fax: 202– Administration (FDA or Agency) is Additional Information: Copies of the 395–7285, Email: OIRA_SUBMISSION@ issuing an order under the Federal proposed collection may be obtained by OMB.EOP.GOV, Attn: Desk Officer for Food, Drug, and Cosmetic Act (the writing to the Administration for the Administration for Children and FD&C Act) permanently debarring Syed Families. Huda from providing services in any Children and Families, Office of capacity to a person that has an Planning, Research and Evaluation, 370 Robert Sargis, approved or pending drug product L’Enfant Promenade, SW., Washington, Reports Clearance Officer. application. FDA bases this order on a DC 20447, Attn: ACF Reports Clearance [FR Doc. 2015–23179 Filed 9–15–15; 8:45 am] finding that Mr. Huda was convicted of Officer. All requests should be BILLING CODE 4184–01–P two felonies under Federal law for identified by the title of the information conduct relating to the regulation of a collection. Email address: drug product. Mr. Huda was given infocollection@acf.hhs.gov. DEPARTMENT OF HEALTH AND notice of the proposed permanent HUMAN SERVICES debarment and an opportunity to OMB Comment: OMB is required to make a decision concerning the Food and Drug Administration request a hearing within the timeframe collection of information between 30 prescribed by regulation. Mr. Huda asabaliauskas on DSK7TPTVN1PROD with NOTICES and 60 days after publication of this failed to respond. Mr. Huda’s failure to [Docket No. FDA–2014–N–2102] respond constitutes a waiver of his right document in the Federal Register. Therefore, a comment is best assured of to a hearing concerning this action. Syed Huda: Debarment Order having its full effect if OMB receives it DATES: This order is effective September within 30 days of publication. Written AGENCY: Food and Drug Administration, 16, 2015. comments and recommendations for the HHS. ADDRESSES: Submit applications for proposed information collection should special termination of debarment to the ACTION: Notice. be sent directly to the following: Division of Dockets Management (HFA– VerDate Sep<11>2014 18:18 Sep 15, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1


Document Created: 2018-02-26 10:16:38
Document Modified: 2018-02-26 10:16:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 55631 
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