83_FR_4043 83 FR 4024 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Virus-Serum-Toxin Act and Regulations

83 FR 4024 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Virus-Serum-Toxin Act and Regulations

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 19 (January 29, 2018)

Page Range4024-4025
FR Document2018-01576

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the Virus-Serum-Toxin Act and regulations.

Federal Register, Volume 83 Issue 19 (Monday, January 29, 2018) 
[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4024-4025]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01576]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0001]


Notice of Request for Revision to and Extension of Approval of an 
Information Collection; Virus-Serum-Toxin Act and Regulations

ACTION: Revision to and extension of approval of an information 
collection; comment request.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this 
notice announces the Animal and Plant Health Inspection Service's 
intention to request a revision to and extension of approval of an 
information collection associated with the Virus-Serum-Toxin Act and 
regulations.

DATES: We will consider all comments that we receive on or before March 
30, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0001, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0001 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: For information on the regulations 
related to the Virus-Serum-Toxin Act and regulations, contact Dr. Donna 
Malloy, Section Leader, Operational Support, Center for Veterinary 
Biologics Policy, Evaluation, and Licensing, VS, APHIS,4700 River Road 
Unit 148, Riverdale, MD 20737-1236; (301) 851-3426. For copies of more 
detailed information on the information collection, contact Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2483.

SUPPLEMENTARY INFORMATION:
    Title: Virus-Serum-Toxin Act and Regulations.
    OMB Control Number: 0579-0013.
    Type of Request: Revision to and extension of approval of an 
information collection.
    Abstract: Under the Virus-Serum-Toxin Act (21 U.S.C. 151-159), the 
Animal and Plant Health Inspection Service (APHIS) is authorized to 
promulgate regulations designed to prevent the importation, 
preparation, sale, or shipment of harmful veterinary biological 
products. These regulations are contained in 9 CFR parts 102 to 124.
    Veterinary biological products include viruses, serums, toxins, and 
analogous products of natural or synthetic origin such as vaccines, 
antitoxins, or the immunizing components of microorganisms intended for 
the diagnosis, treatment, or prevention of diseases in domestic 
animals.
    APHIS issues licenses to qualified establishments that produce 
veterinary biological products and issues permits to importers seeking 
to import such products into the United States. APHIS also enforces 
regulations concerning production, packaging, labeling, and shipping of 
these products, and sets standards for the testing of these products. 
These regulations ensure that veterinary biological products used in 
the United States are not worthless, contaminated, dangerous, or 
harmful.
    To help ensure that veterinary biological products used in the 
United States are pure, safe, potent, and effective, APHIS requires 
certain information collection activities, including, among other 
things, establishment, personnel qualification, and product licenses; 
product permits; packaging and labeling; requests for materials; 
shipment authorizations; product and test reports; preparation and 
usage requests; development and field study summaries; stop 
distribution and sale notifications and inventories; due diligence 
petitions; and recordkeeping.
    The information collection activities above are currently approved 
by the Office of Management and Budget (OMB) for the Virus-Serum-Toxin 
Act and regulations under OMB control numbers 0579-0013 and 0579-0460. 
After OMB approves this combined information collection package (0579-
0013), APHIS will retire OMB control number 0579-0460.
    We are asking OMB to approve our use of these information 
collection activities, as described, for an additional 3 years.
    The purpose of this notice is to solicit comments from the public 
(as well as affected agencies) concerning our information collection. 
These comments will help us:
    (1) Evaluate whether the 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 our estimate of the burden of the 
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, through use, as appropriate, of automated, 
electronic, mechanical, and other collection technologies; e.g., 
permitting electronic submission of responses.
    Estimate of burden: The public burden for this collection of 
information is estimated to average 0.001 hours per response.
    Respondents: Veterinary biological product developers and 
producers, foreign government officials, State government officials, 
and private individuals.
    Estimated annual number of respondents: 405.
    Estimated annual number of responses per respondent: 737,790.
    Estimated annual number of responses: 298,804,802.
    Estimated total annual burden on respondents: 91,000 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.


[[Page 4025]]


    Done in Washington, DC, this 24th day of January 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-01576 Filed 1-26-18; 8:45 am]
 BILLING CODE 3410-34-P

4024 Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices Estimated annual number of through Friday, except holidays. To be field study summaries; stop distribution responses: 51,437,932. sure someone is there to help you, and sale notifications and inventories; Estimated total annual burden on please call (202) 799–7039 before due diligence petitions; and respondents: 535,352 hours. (Due to coming. recordkeeping. averaging, the total annual burden hours FOR FURTHER INFORMATION CONTACT: For The information collection activities may not equal the product of the annual information on the regulations related to above are currently approved by the number of responses multiplied by the the Virus-Serum-Toxin Act and Office of Management and Budget reporting burden per response.) regulations, contact Dr. Donna Malloy, (OMB) for the Virus-Serum-Toxin Act All responses to this notice will be Section Leader, Operational Support, and regulations under OMB control summarized and included in the request Center for Veterinary Biologics Policy, numbers 0579–0013 and 0579–0460. for OMB approval. All comments will Evaluation, and Licensing, VS, After OMB approves this combined also become a matter of public record. APHIS,4700 River Road Unit 148, information collection package (0579– Done in Washington, DC, this 23rd day of Riverdale, MD 20737–1236; (301) 851– 0013), APHIS will retire OMB control January 2018. 3426. For copies of more detailed number 0579–0460. Kevin Shea, information on the information We are asking OMB to approve our Administrator, Animal and Plant Health collection, contact Ms. Kimberly Hardy, use of these information collection Inspection Service. APHIS’ Information Collection activities, as described, for an additional [FR Doc. 2018–01575 Filed 1–26–18; 8:45 am] Coordinator, at (301) 851–2483. 3 years. BILLING CODE 3410–34–P SUPPLEMENTARY INFORMATION: The purpose of this notice is to solicit Title: Virus-Serum-Toxin Act and comments from the public (as well as Regulations. affected agencies) concerning our DEPARTMENT OF AGRICULTURE OMB Control Number: 0579–0013. information collection. These comments Type of Request: Revision to and will help us: Animal and Plant Health Inspection extension of approval of an information (1) Evaluate whether the collection of Service collection. information is necessary for the proper [Docket No. APHIS–2018–0001] Abstract: Under the Virus-Serum- performance of the functions of the Toxin Act (21 U.S.C. 151–159), the Agency, including whether the Notice of Request for Revision to and Animal and Plant Health Inspection information will have practical utility; Extension of Approval of an Service (APHIS) is authorized to (2) Evaluate the accuracy of our Information Collection; Virus-Serum- promulgate regulations designed to estimate of the burden of the collection Toxin Act and Regulations prevent the importation, preparation, of information, including the validity of sale, or shipment of harmful veterinary the methodology and assumptions used; ACTION:Revision to and extension of biological products. These regulations (3) Enhance the quality, utility, and approval of an information collection; are contained in 9 CFR parts 102 to 124. clarity of the information to be comment request. Veterinary biological products collected; and include viruses, serums, toxins, and (4) Minimize the burden of the SUMMARY: In accordance with the analogous products of natural or Paperwork Reduction Act of 1995, this collection of information on those who synthetic origin such as vaccines, are to respond, through use, as notice announces the Animal and Plant antitoxins, or the immunizing Health Inspection Service’s intention to appropriate, of automated, electronic, components of microorganisms mechanical, and other collection request a revision to and extension of intended for the diagnosis, treatment, or approval of an information collection technologies; e.g., permitting electronic prevention of diseases in domestic submission of responses. associated with the Virus-Serum-Toxin animals. Act and regulations. Estimate of burden: The public APHIS issues licenses to qualified DATES: We will consider all comments burden for this collection of information establishments that produce veterinary that we receive on or before March 30, is estimated to average 0.001 hours per biological products and issues permits 2018. response. to importers seeking to import such ADDRESSES: You may submit comments products into the United States. APHIS Respondents: Veterinary biological by either of the following methods: also enforces regulations concerning product developers and producers, • Federal eRulemaking Portal: Go to production, packaging, labeling, and foreign government officials, State http://www.regulations.gov/#!docket shipping of these products, and sets government officials, and private Detail;D=APHIS-2018-0001. standards for the testing of these individuals. • Postal Mail/Commercial Delivery: products. These regulations ensure that Estimated annual number of Send your comment to Docket No. veterinary biological products used in respondents: 405. APHIS–2018–0001, Regulatory Analysis the United States are not worthless, Estimated annual number of and Development, PPD, APHIS, Station contaminated, dangerous, or harmful. responses per respondent: 737,790. 3A–03.8, 4700 River Road Unit 118, To help ensure that veterinary Estimated annual number of Riverdale, MD 20737–1238. biological products used in the United responses: 298,804,802. Supporting documents and any States are pure, safe, potent, and Estimated total annual burden on comments we receive on this docket effective, APHIS requires certain respondents: 91,000 hours. (Due to may be viewed at http:// information collection activities, averaging, the total annual burden hours sradovich on DSK3GMQ082PROD with NOTICES www.regulations.gov/#!docketDetail;D= including, among other things, may not equal the product of the annual APHIS-2018-0001 or in our reading establishment, personnel qualification, number of responses multiplied by the room, which is located in room 1141 of and product licenses; product permits; reporting burden per response.) the USDA South Building, 14th Street packaging and labeling; requests for All responses to this notice will be and Independence Avenue SW, materials; shipment authorizations; summarized and included in the request Washington, DC. Normal reading room product and test reports; preparation for OMB approval. All comments will hours are 8 a.m. to 4:30 p.m., Monday and usage requests; development and also become a matter of public record. VerDate Sep<11>2014 18:19 Jan 26, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\29JAN1.SGM 29JAN1

Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices 4025 Done in Washington, DC, this 24th day of intergovernmental consultation with However, the combined rate is based on January 2018. State and local officials. (See 2 CFR part separate operating and administrative Kevin Shea, 415 and final rule-related notice rates of reimbursement, each of which is Administrator, Animal and Plant Health published at 48 FR 29114, June 24, adjusted differently for inflation. Inspection Service. 1983.) [FR Doc. 2018–01576 Filed 1–26–18; 8:45 am] In accordance with the Paperwork Calculation of Rates BILLING CODE 3410–34–P Reduction Act of 1995, 44 U.S.C. 3501– The combined rates are constructed 3520, no new recordkeeping or from individually authorized operating reporting requirements have been and administrative reimbursements. DEPARTMENT OF AGRICULTURE included that are subject to approval Simplified procedures provide from the Office of Management and Food and Nutrition Service flexibility, enabling sponsors to manage Budget. This notice is not a rule as defined by their reimbursements to pay for any Summer Food Service Program 2018 the Regulatory Flexibility Act, 5 U.S.C. allowable cost, regardless of the cost Reimbursement Rates 601–612, and thus is exempt from the category. Sponsors remain responsible, provisions of that Act. Additionally, this however, for ensuring proper AGENCY: Food and Nutrition Service, administration of the Program, while USDA. notice has been determined to be exempt from formal review by the Office providing the best possible nutrition ACTION: Notice. benefit to children. of Management and Budget under SUMMARY: This notice informs the public Executive Order 12866. The operating and administrative of the annual adjustments to the rates are calculated separately. Definitions reimbursement rates for meals served in However, the calculations of the Summer Food Service Program for The terms used in this notice have the adjustments for both cost categories are Children. These adjustments address meaning ascribed to them under 7 CFR based on the same set of changes in the changes in the Consumer Price Index, as part 225 of the SFSP regulations. Food Away From Home series of the required under the Richard B. Russell Background Consumer Price Index for All Urban National School Lunch Act. The 2018 Consumers, published by the Bureau of reimbursement rates are presented as a This notice informs the public of the Labor Statistics of the United States combined set of rates to highlight annual adjustments to the Department of Labor. They represent a simplified cost accounting procedures. reimbursement rates for meals served in 2.4 percent increase in this series for the The 2018 rates are also presented SFSP. In accordance with sections 12(f) 12-month period, from November 2016 individually, as separate operating and and 13, 42 U.S.C. 1760(f) and 1761, of through November 2017 (from 264.699 administrative rates of reimbursement, the Richard B. Russell National School in November 2016 to 271.152 in to show the effect of the Consumer Price Lunch Act (NSLA) and SFSP regulations November 2017). Index adjustment on each rate. under 7 CFR part 225, the United States Department of Agriculture announces Table of 2018 Reimbursement Rates DATES: January 1, 2018. the adjustments in SFSP payments for FOR FURTHER INFORMATION CONTACT: meals served to participating children Presentation of the 2018 maximum Jessica Saracino, Program Monitoring during calendar year 2018. per meal rates for meals served to and Operational Support Division, The 2018 reimbursement rates are children in SFSP combines the results Child Nutrition Programs, Food and presented as a combined set of rates to from the calculations of operational and Nutrition Service, United States highlight simplified cost accounting administrative payments, which are Department of Agriculture, 3101 Park procedures. Reimbursement is based further explained in this notice. The Center Drive, Suite 628, Alexandria, solely on a ‘‘meals times rate’’ total amount of payments to State Virginia 22302. calculation, without comparison to agencies for disbursement to SFSP SUPPLEMENTARY INFORMATION: The actual or budgeted costs. sponsors will be based upon these Summer Food Service Program (SFSP) Sponsors receive reimbursement that adjusted combined rates and the is listed in the Catalog of Federal is determined by the number of number of meals of each type served. Domestic Assistance under No. 10.559 reimbursable meals served, multiplied These adjusted rates will be in effect and is subject to the provisions of by the combined rates for food service from January 1, 2018 through December Executive Order 12372, which requires operations and administration. 31, 2018. SUMMER FOOD SERVICE PROGRAM 2018 REIMBURSEMENT RATES [Combined] All states except Alaska Alaska Hawaii and Hawaii Per meal rates in whole or fractions of Rural or All other Rural or All other U.S. dollars Rural or All other self-prep types of self-prep types of self-prep types of sites sites sites sites sites sites Breakfast .................................................. 2.2325 2.1900 3.6275 3.5600 2.6175 2.5675 sradovich on DSK3GMQ082PROD with NOTICES Lunch or Supper ...................................... 3.9225 3.8575 6.3625 6.2600 4.5950 4.5200 Snack ....................................................... 0.9300 0.9100 1.5025 1.4700 1.0875 1.0625 Operating Rates amounts set in section 13(b)(1) of the cent, as required by section The portion of the SFSP rates for NSLA, 42 U.S.C. 1761(b)(1). They are 11(a)(3)(B)(iii) of the NSLA, 42 U.S.C. operating costs is based on payment rounded down to the nearest whole 1759a(a)(3)(B)(iii). 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Document Created: 2018-01-27 00:58:03
Document Modified: 2018-01-27 00:58:03
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
ActionRevision to and extension of approval of an information collection; comment request.
DatesWe will consider all comments that we receive on or before March 30, 2018.
ContactFor information on the regulations related to the Virus-Serum-Toxin Act and regulations, contact Dr. Donna Malloy, Section Leader, Operational Support, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS,4700 River Road Unit 148, Riverdale, MD 20737-1236; (301) 851-3426. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
FR Citation83 FR 4024 
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