80_FR_45686 80 FR 45540 - Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Extension of Comment Period

80 FR 45540 - Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range45540-45541
FR Document2015-18668

The Food and Drug Administration (FDA or we) is extending the comment period for the risk assessment entitled ``Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.'' A notice of the availability of the risk assessment and our request for comments appeared in the Federal Register of April 30, 2015. We initially established July 29, 2015, as the deadline for the submission of requested comments that can help improve the ranking model approach, including the specific criteria, scoring, and weighting scheme; the scientific data and assumptions used to inform scoring used in the model; the selection of animal drugs evaluated; and the clarity and the transparency of the risk assessment. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015) 
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45540-45541]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1305]


Multicriteria-Based Ranking Model for Risk Management of Animal 
Drug Residues in Milk and Milk Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the risk assessment entitled ``Multicriteria-Based 
Ranking Model for Risk Management of Animal Drug Residues in Milk and 
Milk Products.'' A notice of the availability of the risk assessment 
and our request for comments appeared in the Federal Register of April 
30, 2015. We initially established July 29, 2015, as the deadline for 
the submission of requested comments that can help improve the ranking 
model approach, including the specific criteria, scoring, and weighting 
scheme; the scientific data and assumptions used to inform scoring used 
in the model; the selection of animal drugs evaluated; and the clarity 
and the transparency of the risk assessment. We are taking this action 
in response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the risk assessment whose 
availability we announced in a notice published on April 30, 2015 (80 
FR 24260). Submit either electronic or written comments on the risk 
assessment by October 27, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1305. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of April 30, 2015, FDA published a notice 
announcing the availability of a risk assessment entitled 
``Multicriteria-Based Ranking Model for Risk Management of Animal Drug 
Residues in Milk and Milk Products,'' with a 90-day comment period to 
request comments on the risk assessment.
    We received a request for a 90-day extension of the comment period 
for the risk assessment. The request conveyed concern that the current 
90-day comment period does not allow sufficient time to develop 
meaningful or thoughtful comments to the risk assessment.
    FDA has considered the request and is extending the comment period 
for the risk assessment for 90 days, until October 27, 2015. We believe 
that a 90-

[[Page 45541]]

day extension allows adequate time for interested persons to submit 
comments.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the risk assessment 
at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm.

    Dated: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18668 Filed 7-29-15; 8:45 am]
 BILLING CODE 4164-01-P

45540 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices DATES: The Agency will consider public review and clearance under 44 U.S.C. ADDRESSES: You may submit comments comments on the settlement until 3507. An Agency may not conduct or by any of the following methods: August 31, 2015. The Agency will sponsor, and a person is not required to Electronic Submissions consider all comments received and respond to, a collection of information may modify or withdraw its consent to unless it displays a currently valid OMB Submit electronic comments in the the settlement if comments received control number. OMB has now following way: disclose facts or considerations which approved the information collection and • Federal eRulemaking Portal: http:// indicate that the amended settlement is has assigned OMB control number www.regulations.gov. Follow the inappropriate, improper, or inadequate. 0910–0275. The approval expires on instructions for submitting comments. ADDRESSES: Copies of the settlement are July 31, 2018. A copy of the supporting Written Submissions available from the Agency by contacting statement for this information collection Ms. Paula V. Painter, Environmental is available on the Internet at http:// Submit written submissions in the Protection Specialist using the contact www.reginfo.gov/public/do/PRAMain. following ways: information provided in this notice. • Mail/Hand delivery/Courier (for Dated: July 24, 2015. Comments may also be submitted by paper submissions): Division of Dockets Leslie Kux, referencing the Site’s name through one Management (HFA–305), Food and Drug Associate Commissioner for Policy. Administration, 5630 Fishers Lane, Rm. of the following methods: [FR Doc. 2015–18649 Filed 7–29–15; 8:45 am] • Internet: www.epa.gov/region4/ 1061, Rockville, MD 20852. superfund/programs/enforcement/ BILLING CODE 4164–01–P Instructions: All submissions received enforcement.html. must include the Docket No. FDA– • U.S. Mail: U.S. Environmental 2015–N–1305. All comments received DEPARTMENT OF HEALTH AND may be posted without change to http:// Protection Agency, Superfund Division, HUMAN SERVICES Attn: Paula V. Painter, 61 Forsyth Street www.regulations.gov, including any SW., Atlanta, Georgia 30303. personal information provided. For Food and Drug Administration • Email: Painter.Paula@epa.gov. additional information on submitting comments, see the ‘‘Comments’’ heading FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2015–N–1305] of the SUPPLEMENTARY INFORMATION Paula V. Painter at (404) 562–8887. section of this document. Dated: June 9, 2015. Multicriteria-Based Ranking Model for Docket: For access to the docket to Anita L. Davis, Risk Management of Animal Drug read background documents or Residues in Milk and Milk Products; Chief, Enforcement and Community comments received, go to http:// Engagement Branch, Superfund Division. Extension of Comment Period www.regulations.gov and insert the [FR Doc. 2015–18727 Filed 7–29–15; 8:45 am] AGENCY: Food and Drug Administration, docket number(s), found in brackets in BILLING CODE 6560–50–P HHS. the heading of this document, into the ACTION: Notice; extension of comment ‘‘Search’’ box and follow the prompts period. and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND Management, 5630 Fishers Lane, Rm. HUMAN SERVICES SUMMARY: The Food and Drug 1061, Rockville, MD 20852. Administration (FDA or we) is FOR FURTHER INFORMATION CONTACT: Jane Food and Drug Administration extending the comment period for the Van Doren, Center for Food Safety and [Docket No. FDA–2008–N–0397] risk assessment entitled ‘‘Multicriteria- Applied Nutrition (HFS–005), Food and Based Ranking Model for Risk Drug Administration, 5100 Paint Branch Agency Information Collection Management of Animal Drug Residues Pkwy., College Park, MD 20740, 240– Activities; Announcement of Office of in Milk and Milk Products.’’ A notice of 402–2927. Management and Budget Approval; the availability of the risk assessment SUPPLEMENTARY INFORMATION: State Enforcement Notifications and our request for comments appeared in the Federal Register of April 30, I. Background AGENCY: Food and Drug Administration, 2015. We initially established July 29, In the Federal Register of April 30, HHS. 2015, as the deadline for the submission 2015, FDA published a notice ACTION: Notice. of requested comments that can help announcing the availability of a risk improve the ranking model approach, assessment entitled ‘‘Multicriteria-Based SUMMARY: The Food and Drug including the specific criteria, scoring, Administration (FDA) is announcing Ranking Model for Risk Management of and weighting scheme; the scientific Animal Drug Residues in Milk and Milk that a collection of information entitled, data and assumptions used to inform ‘‘State Enforcement Notifications’’ has Products,’’ with a 90-day comment scoring used in the model; the selection period to request comments on the risk been approved by the Office of of animal drugs evaluated; and the Management and Budget (OMB) under assessment. clarity and the transparency of the risk We received a request for a 90-day the Paperwork Reduction Act of 1995. assessment. We are taking this action in extension of the comment period for the FOR FURTHER INFORMATION CONTACT: FDA response to a request for an extension to risk assessment. The request conveyed PRA Staff, Office of Operations, Food allow interested persons additional time concern that the current 90-day and Drug Administration, 8455 to submit comments. comment period does not allow Colesville Rd., COLE–14526, Silver Lhorne on DSK7TPTVN1PROD with NOTICES DATES: FDA is extending the comment sufficient time to develop meaningful or Spring, MD 20993–0002, PRAStaff@ period on the risk assessment whose thoughtful comments to the risk fda.hhs.gov. availability we announced in a notice assessment. SUPPLEMENTARY INFORMATION: On June 8, published on April 30, 2015 (80 FR FDA has considered the request and 2015, the Agency submitted a proposed 24260). Submit either electronic or is extending the comment period for the collection of information entitled, ‘‘State written comments on the risk risk assessment for 90 days, until Enforcement Notifications’’ to OMB for assessment by October 27, 2015. October 27, 2015. We believe that a 90- VerDate Sep<11>2014 14:54 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\30JYN1.SGM 30JYN1

Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices 45541 day extension allows adequate time for required to respond to, a collection of Extramural Research Administration, interested persons to submit comments. information unless it displays a 6705 Rockledge Drive, Suite 350, currently valid OMB control number. Bethesda, Maryland 20892, or call a II. Request for Comments OMB has now approved the information non-toll-free number 301–435–0941 or Interested persons may submit either collection and has assigned OMB Email your request, including your electronic comments regarding this control number 0910–0363. The address to curriem@mail.nih.gov. document to http://www.regulations.gov approval expires on July 31, 2018. A Formal requests for additional plans and or written comments to the Division of copy of the supporting statement for this instruments must be requested in Dockets Management (see ADDRESSES). It information collection is available on writing. is only necessary to send one set of the Internet at http://www.reginfo.gov/ Comments Due Date: Comments comments. Identify comments with the public/do/PRAMain. regarding this information collection are docket number found in brackets in the Dated: July 24, 2015. best assured of having their full effect if heading of this document. Received received within 60 days of the date of Leslie Kux, comments may be seen in the Division this publication. Associate Commissioner for Policy. of Dockets Management between 9 a.m. Proposed Collection: Conference, and 4 p.m., Monday through Friday, and [FR Doc. 2015–18650 Filed 7–29–15; 8:45 am] Meeting, Workshop, and Poster Session will be posted to the docket at http:// BILLING CODE 4164–01–P Registration Generic Clearance (OD), www.regulations.gov. 0925–New, National Institutes of Health III. Electronic Access DEPARTMENT OF HEALTH AND (NIH), Office of the Director (OD). HUMAN SERVICES Need and Use of Information Persons with access to the Internet Collection: The information collections may obtain the risk assessment at http:// National Institutes of Health encompassed by this generic clearance www.fda.gov/Food/ will allow the NIH to select the most FoodScienceResearch/ Proposed Collection; 60 Day Comment appropriate participants for non-grantee RiskSafetyAssessment/ucm443549.htm. Request Conference, Meeting, activities sponsored, organized, and run Dated: July 24, 2015. Workshop, and Poster Session by the NIH staff, according to the type Leslie Kux, Registration Generic Clearance (OD) and purpose of the activity. For Associate Commissioner for Policy. Summary: In compliance with the example, the NIH may develop an [FR Doc. 2015–18668 Filed 7–29–15; 8:45 am] requirement of Section 3506(c)(2)(A) of application process or information BILLING CODE 4164–01–P the Paperwork Reduction Act of 1995, collection to select a limited number of for opportunity for public comment on researchers to participate in a poster proposed data collection projects, the session, identify speakers and panelists DEPARTMENT OF HEALTH AND National Institutes of Health (NIH), with desired expertise on a specific HUMAN SERVICES Office of the Director (OD), will publish topic to be covered at a meeting, or periodic summaries of proposed determine which researchers would Food and Drug Administration most likely benefit from a training projects to the Office of Management [Docket No. FDA–2010–N–0155] and Budget (OMB) for review and course or other opportunity. For the NIH approval. to plan and conduct activities that are Agency Information Collection Written comments and/or suggestions timely for participants and their fields Activities; Announcement of Office of from the public and affected agencies of research, it is often necessary for such Management and Budget Approval; are invited on one or more of the information to be collected with a Veterinary Feed Directive following points: (1) Whether the relatively short turnaround time. In proposed collection of information is general, submitted abstracts or other AGENCY: Food and Drug Administration, application materials will be reviewed HHS. necessary for the proper performance of the function of the agency, including by an internal NIH committee ACTION: Notice. whether the information will have responsible for planning the activities. practical utility; (2) The accuracy of the This committee will be responsible for SUMMARY: The Food and Drug selecting and notifying participants. Administration (FDA) is announcing agency’s estimate of the burden of the proposed collection of information, The information collected for these that a collection of information entitled including the validity of the activities generally includes title, ‘‘Veterinary Feed Directive’’ has been methodology and assumptions used; (3) author(s), institution/organization, approved by the Office of Management Ways to enhance the quality, utility, and poster size, character limitations along and Budget (OMB) under the Paperwork clarity of the information to be with other requirements. This Reduction Act of 1995. collected; and (4) Ways to minimize the information is necessary to identify FOR FURTHER INFORMATION CONTACT: FDA attendees as eligible for poster burden of the collection of information PRA Staff, Office of Operations, Food presentations, to present their research, on those who are to respond, including and Drug Administration, 8455 speak on panels, and discuss innovative the use of appropriate automated, Colesville Rd., COLE–14526, Silver approaches to science and technology to electronic, mechanical, or other Spring, MD 20993–0002, PRAStaff@ their peers. The registration form technological collection techniques or fda.hhs.gov. collects information from interested other forms of information technology. SUPPLEMENTARY INFORMATION: On May To Submit Comments and for Further parties necessary to register them for a Lhorne on DSK7TPTVN1PROD with NOTICES 19, 2015, the Agency submitted a Information: To obtain a copy of the workshop. proposed collection of information data collection plans and instruments, OMB approval is requested for 3 entitled ‘‘Veterinary Feed Directive’’ to submit comments in writing, or request years. There are no costs to respondents OMB for review and clearance under 44 more information on the proposed other than their time. The total U.S.C. 3507. An Agency may not project, contact: Ms. Mikia P. Currie, estimated annualized burden hours are conduct or sponsor, and a person is not Program Analyst, Office of Policy for 8,500. VerDate Sep<11>2014 14:54 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\30JYN1.SGM 30JYN1


Document Created: 2018-02-23 09:30:08
Document Modified: 2018-02-23 09:30:08
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
ActionNotice; extension of comment period.
DatesFDA is extending the comment period on the risk assessment whose availability we announced in a notice published on April 30, 2015 (80 FR 24260). Submit either electronic or written comments on the risk assessment by October 27, 2015.
ContactJane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.
FR Citation80 FR 45540 
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