Advisory Commission on Childhood Vaccines, 23370-23371 [2020-08883]

Download as PDF 23370 Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices lotter on DSKBCFDHB2PROD with NOTICES 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’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–5664 for ‘‘Standardized Medicated Feed Assay Limits.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not VerDate Sep<11>2014 17:32 Apr 24, 2020 Jkt 250001 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Katie Ciesienski, Center for Veterinary Medicine (HFV–141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0676, Katie.Ciesienski@fda.hhs.gov. In the Federal Register of February 27, 2020, FDA published a notice announcing the availability of draft GFI #264 entitled ‘‘Standardized Medicated Feed Assay Limits’’ with a 60-day comment period. This draft guidance recommends a standardized set of assay limits for medicated feeds. Standardized medicated feed assay limits allow predictability in the review process as the sponsor can determine early in the drug development process what assay limits they should expect to meet for medicated feeds used in Target Animal Safety, Effectiveness, Chemistry, Manufacturing, and Controls, Bioequivalence, and Human Food Safety residue chemistry studies. Assay limits are used pre-approval to ensure that medicated feeds in these studies contain the appropriate amount of drug, and post-approval for compliance and customer service purposes. The Agency has received a request for a 90-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a comprehensive response. FDA has considered the request and is extending the comment period for the notice of availability for 60 days, until June 26, 2020. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Dated: April 21, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–08890 Filed 4–24–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary’s Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https://www.hrsa.gov/advisorycommittees/vaccines. DATES: May 18, 2020. This meeting will begin at 9:00 a.m. ET. ADDRESSES: This meeting will be held by Adobe Connect webinar and teleconference. • Webinar link: https:// hrsa.connectsolutions.com/accv/. • Conference call-in number: 888– 790–1734, passcode: 4177683. FOR FURTHER INFORMATION CONTACT: Annie Herzog, Division of Injury Compensation Programs, HRSA, 5600 Fishers Lane, 08N186B, Rockville, Maryland 20857; 301–443–6634; or aherzog@HRSA.gov. SUPPLEMENTARY INFORMATION: The ACCV provides advice and recommendations to the Secretary of HHS on policy, program development, and other issues related to implementation of the National Vaccine Injury Compensation Program (VICP) and concerning other matters as described under section 2119 of the Public Health Service Act (42 U.S.C. 300aa–19). During the May 18, 2020, meeting, the ACCV will discuss a draft VICP Notice of Proposed Rulemaking. Agenda items are subject to change as priorities dictate. Refer to the ACCV website for any updated information concerning the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested SUMMARY: E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices and may be limited as time allows. Requests to submit a written statement or make oral comments to ACCV should be sent to Annie Herzog, ACCV Principal Staff Liaison, using the contact information above at least 5 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Annie Herzog at the address and phone number listed above at least 10 business days prior to the meeting. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–08883 Filed 4–24–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615–0135] Agency Information Collection Activities; Revision, of a Currently Approved Collection: Application for Carrier Documentation U.S. Citizenship and Immigration Services, Department of Homeland Security. ACTION: 30-Day notice. AGENCY: The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments. DATES: Comments are encouraged and will be accepted until May 27, 2020. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1615–0135 in the body of the letter, the agency name and Docket ID USCIS–2015–0004. Submit comments via the Federal eRulemaking Portal website at http:// www.regulations.gov under e-Docket ID number USCIS–2015–0004. FOR FURTHER INFORMATION CONTACT: USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, Telephone number (202) 272–8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact lotter on DSKBCFDHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Apr 24, 2020 Jkt 250001 information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http:// www.uscis.gov, or call the USCIS Contact Center at (800) 375–5283; TTY (800) 767–1833. SUPPLEMENTARY INFORMATION: Comments The information collection notice was previously published in the Federal Register on December 18, 2019, at 84 FR 69387, allowing for a 60-day public comment period. USCIS did receive 3 comments in connection with the 60day notice. You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS–2015–0004 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http:// www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed 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, including through the PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 23371 use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection Request: Revision of a Currently Approved Collection. (2) Title of the Form/Collection: Application for Carrier Documentation. (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I–131A; USCIS. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information provided on Form I–131A to verify the status of (1) permanent or conditional residents or (2) non-permanent or conditional residents who hold an advance parole document and determine whether the applicant is eligible for the requested carrier documentation. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I–131A is 5,100 and the estimated hour burden per response is .92 hours; biometrics processing is 5,100 and the estimated hour burden per response is 1.17 hours. (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 10,659 hours. (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $919,275. Dated: April 21, 2020. Samantha L. Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. 2020–08833 Filed 4–24–20; 8:45 am] BILLING CODE 9111–97–P E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Notices]
[Pages 23370-23371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Secretary's Advisory Commission on Childhood 
Vaccines (ACCV) has scheduled a public meeting. Information about ACCV 
and the agenda for this meeting can be found on the ACCV website at 
https://www.hrsa.gov/advisory-committees/vaccines.

DATES: May 18, 2020. This meeting will begin at 9:00 a.m. ET.

ADDRESSES: This meeting will be held by Adobe Connect webinar and 
teleconference.
     Webinar link: https://hrsa.connectsolutions.com/accv/.
     Conference call-in number: 888-790-1734, passcode: 
4177683.

FOR FURTHER INFORMATION CONTACT: Annie Herzog, Division of Injury 
Compensation Programs, HRSA, 5600 Fishers Lane, 08N186B, Rockville, 
Maryland 20857; 301-443-6634; or [email protected].

SUPPLEMENTARY INFORMATION: The ACCV provides advice and recommendations 
to the Secretary of HHS on policy, program development, and other 
issues related to implementation of the National Vaccine Injury 
Compensation Program (VICP) and concerning other matters as described 
under section 2119 of the Public Health Service Act (42 U.S.C. 300aa-
19).
    During the May 18, 2020, meeting, the ACCV will discuss a draft 
VICP Notice of Proposed Rulemaking. Agenda items are subject to change 
as priorities dictate. Refer to the ACCV website for any updated 
information concerning the meeting.
    Members of the public will have the opportunity to provide 
comments. Public participants may submit written statements in advance 
of the scheduled meeting. Oral comments will be honored in the order 
they are requested

[[Page 23371]]

and may be limited as time allows. Requests to submit a written 
statement or make oral comments to ACCV should be sent to Annie Herzog, 
ACCV Principal Staff Liaison, using the contact information above at 
least 5 business days prior to the meeting. Individuals who plan to 
attend and need special assistance or another reasonable accommodation 
should notify Annie Herzog at the address and phone number listed above 
at least 10 business days prior to the meeting.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-08883 Filed 4-24-20; 8:45 am]
 BILLING CODE 4165-15-P