Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine, 10581-10582 [2021-03431]

Download as PDF Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices Minerals, LLC (Prince) in Leesburg, Alabama meet the applicability criteria of NESHAP subparts BBBBBBB, CCCCCCC, and/or VVVVVV? A: Based on the information provided, EPA determines that Prince’s frit production processes meet the applicability criteria of subpart CCCCCCC and do not meet the applicability criteria for subparts BBBBBBB and VVVVVV. Subpart CCCCCCC is applicable to Prince’s facility because the subpart lists NAICS code 3255 and defines ‘‘paints and allied products manufacturing’’ as the production of paints and allied products (e.g., coatings) intended to ‘‘leave a dried film of solid material on a substrate,’’ and the subpart defines ‘‘material containing HAP’’ as including any material containing nickel in amounts greater than 0.1 percent by weight. Subpart BBBBBBB defines ‘‘chemical preparation’’ as being manufactured in a process described by the NAICS code 325998, so subpart BBBBBBB is not applicable. Subpart VVVVVV includes an applicability exclusion for sources subject to Subpart CCCCCCC, so subpart VVVVVV is not applicable. tkelley on DSKBCP9HB2PROD with NOTICES Abstract for [Z200005] Q: Does EPA approve an alternative monitoring plan (AMP) for six reciprocating internal combustion engines (RICEs) operating at less than 100 percent maximum load during compliance testing at Kinder Morgan Natural Gas Pipeline’s Houston Central Gas Plant in Sheridan, Texas subject to NESHAP subpart ZZZZ? A: Yes. Based on the information provided, EPA conditionally approves an AMP to conduct performance testing for engines COMP–1, COMP–35, and COMP–13C at a maximum engine load of 85 percent with subsequent monitoring required at 85 percent plus or minus 10 percent load, and for engines COMP–349, COMP–350, and COMP–8 at a maximum engine load of 90 percent with subsequent monitoring required at 90 percent plus or minus 10 percent load. EPA agrees that these six RICEs cannot operate at 100 percent plus or minus 10 percent operational load during compliance testing as specified in 40 CFR 63.6620(b)(2) due to site-specific operations. If operations change such that the maximum load of the engines exceeds these alternative lower maximum loads, the AMP will become null and void and retesting at the higher engine load will be required VerDate Sep<11>2014 19:48 Feb 19, 2021 Jkt 253001 to demonstrate compliance with subpart ZZZZ. John Dombrowski, Deputy Director, Office of Compliance, Office of Enforcement and Compliance Assurance. [FR Doc. 2021–03489 Filed 2–19–21; 8:45 am] BILLING CODE 6560–50–P 10581 Audit Division Recommendation Memorandum on Dr. Raul Ruiz for Congress (A19–03) Management and Administrative Matters CONTACT PERSON FOR MORE INFORMATION: Judith Ingram, Press Officer. Telephone: (202) 694–1220. Authority: Government in the Sunshine Act, 5 U.S.C. 552b FEDERAL ELECTION COMMISSION Sunshine Act Meetings Laura E. Sinram, Acting Secretary and Clerk of the Commission. Thursday, February 25, 2021 at 10:00 a.m. PLACE: Virtual hearing. Note: Because of the covid-19 pandemic, we will conduct the hearing virtually. If you would like to access the hearing, see the instructions below. STATUS: This hearing will be open to the public. To access the virtual hearing, go to the commission’s website www.fec.gov and click on the banner to be taken to the hearing page. MATTERS TO BE CONSIDERED: Repayment Hearing: Jill Stein for President. CONTACT PERSON FOR MORE INFORMATION: Judith Ingram, Press Officer. Telephone: (202) 694–1220. [FR Doc. 2021–03694 Filed 2–18–21; 4:15 pm] Authority: Government in the Sunshine Act, 5 U.S.C. 552b. HHS. TIME AND DATE: Laura E. Sinram, Acting Secretary and Clerk of the Commission. BILLING CODE 6715–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1652] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine AGENCY: ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection [FR Doc. 2021–03692 Filed 2–18–21; 4:15 pm] of information has been submitted to the BILLING CODE 6715–01–P Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FEDERAL ELECTION COMMISSION DATES: Submit written comments Sunshine Act Meetings (including recommendations) on the collection of information by March 24, TIME AND DATE: Thursday, February 25, 2021. 2021 following the conclusion of the ADDRESSES: To ensure that comments on repayment hearing. the information collection are received, PLACE: Virtual meeting. Note: Because of OMB recommends that written the covid-19 pandemic, we will conduct comments be submitted to https:// the open meeting virtually. If you would www.reginfo.gov/public/do/PRAMain. like to access the meeting, see the Find this particular information instructions below. collection by selecting ‘‘Currently under STATUS: This meeting will be open to the Review—Open for Public Comments’’ or public. To access the virtual meeting, go by using the search function. The OMB control number for this information to the commission’s website collection is 0910–0566. Also include www.fec.gov and click on the banner to the FDA docket number found in be taken to the meeting page. brackets in the heading of this MATTERS TO BE CONSIDERED: document. Draft Advisory Opinion 2021–02: Full Employment Now-Political Action FOR FURTHER INFORMATION CONTACT: Ila Committee (FEC–PAC) S. Mizrachi, Office of Operations, Food Draft Advisory Opinion 2021–03: and Drug Administration, Three White National Republican Senatorial Flint North, 10A–12M, 11601 Committee (NRSC) and National Landsdown St., North Bethesda, MD Republican Congressional Committee 20852, 301–796–7726, PRAStaff@ (NRCC) fda.hhs.gov. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\22FEN1.SGM 22FEN1 10582 Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine—21 CFR 10.75 OMB Control Number 0910–0566— Extension The Center for Veterinary Medicine (CVM) Guidance for Industry (GFI) #79, ‘‘Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ (https://www.fda.gov/media/ 70279/download), describes the process by which CVM formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training, or experience to be understood and resolved. The guidance details information on how CVM intends to apply provisions of existing regulations regarding internal review of Agency decisions. In addition, the guidance outlines the established procedures for persons who are sponsors, applicants, or manufacturers of animal drugs or other products regulated by CVM who wish to submit a request for review of a scientific dispute. When a sponsor, applicant, or manufacturer has a scientific disagreement with a written decision by CVM, they may submit a request for a review of that decision by following the established procedures discussed in the guidance. CVM encourages applicants to begin the resolution of science-based disputes with discussions with the review team/ group, including the Team Leader or Division Director. The Center prefers that differences of opinion regarding science or science-based policy be resolved between the review team/group and the applicant. If the matter is not resolved by this preferred method, then CVM recommends that the applicant follow the procedures found in GFI #79. In the Federal Register of August 18, 2020 (85 FR 50827), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 10.75, Request for review of a scientific dispute ................ 1 There Dated: February 11, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–03431 Filed 2–19–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration tkelley on DSKBCP9HB2PROD with NOTICES [Docket No. FDA–2017–N–6931] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘‘Lookback’’ Food and Drug Administration, HHS. ACTION: 1 Total annual responses 4 Average burden per response 4 Total hours 10 40 are no capital costs or operating and maintenance costs associated with this collection of information. We note that the 60-day notice included an inadvertent error in the estimated burden, which has been corrected in table 1. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. AGENCY: Number of responses per respondent Number of respondents 21 CFR part; activity Notice. VerDate Sep<11>2014 19:48 Feb 19, 2021 Jkt 253001 The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information requirements relating to FDA’s regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donation testing, donor notification, and ‘‘lookback’’. DATES: Submit either electronic or written comments on the collection of information by April 23, 2021. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 23, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Notices]
[Pages 10581-10582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03431]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1652]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Dispute Resolution 
Procedures for Science-Based Decisions on Products by the Center for 
Veterinary Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by March 24, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0566. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

[[Page 10582]]


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Dispute Resolution Procedures for Science-Based Decisions on Products 
by the Center for Veterinary Medicine--21 CFR 10.75

OMB Control Number 0910-0566--Extension

    The Center for Veterinary Medicine (CVM) Guidance for Industry 
(GFI) #79, ``Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' (https://www.fda.gov/media/70279/download), describes the process by which CVM 
formally resolves disputes relating to scientific controversies. A 
scientific controversy involves issues concerning a specific product 
regulated by CVM related to matters of technical expertise and requires 
specialized education, training, or experience to be understood and 
resolved. The guidance details information on how CVM intends to apply 
provisions of existing regulations regarding internal review of Agency 
decisions. In addition, the guidance outlines the established 
procedures for persons who are sponsors, applicants, or manufacturers 
of animal drugs or other products regulated by CVM who wish to submit a 
request for review of a scientific dispute. When a sponsor, applicant, 
or manufacturer has a scientific disagreement with a written decision 
by CVM, they may submit a request for a review of that decision by 
following the established procedures discussed in the guidance.
    CVM encourages applicants to begin the resolution of science-based 
disputes with discussions with the review team/group, including the 
Team Leader or Division Director. The Center prefers that differences 
of opinion regarding science or science-based policy be resolved 
between the review team/group and the applicant. If the matter is not 
resolved by this preferred method, then CVM recommends that the 
applicant follow the procedures found in GFI #79.
    In the Federal Register of August 18, 2020 (85 FR 50827), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
      21 CFR part; activity          Number of     responses per   Total  annual    burden per     Total  hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.75, Request for review of a                 1               4               4              10              40
 scientific dispute.............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We note that the 60-day notice included an inadvertent error in the 
estimated burden, which has been corrected in table 1. Based on a 
review of the information collection since our last request for OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03431 Filed 2-19-21; 8:45 am]
BILLING CODE 4164-01-P
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