Blood Products Advisory Committee; Postponed, 16368-16369 [2020-06082]

Download as PDF 16368 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices focus groups, automated and electronic technology (e.g., email, Web-based surveys), and telephone surveys. Systematic surveys of several groups will be folded into the program. Among these are Federal customers and policy makers, state and local officials who rely on NCHS data, the broader educational, research, and public health community, and other data users. Respondents may include data users who register for and/or attend NCHS sponsored conferences; persons who access the NCHS website and the detailed data available through it; consultants; and others. Respondent data items may include (in broad categories) information regarding respondent’s gender, age, occupation, affiliation, location, etc., to be used to characterize responses only. Other questions will attempt to obtain information that will characterize the respondents’ familiarity with and use of NCHS data, their assessment of data content and usefulness, general satisfaction with available services and products, and suggestions for improvement of surveys, services and products. In order to capture anticipated feedback opportunities, this extension request allows a total estimated annual burden total of 4,000 hours. There is no cost to respondents other than their time to participate in the survey. The resulting information will be for NCHS internal use. Proposed Project 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 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 use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Customer Surveys Generic Clearance for the National Center for Health Statistics (OMB Control No. 0920–0729, Exp. 09/30/2020)—Extension—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on ‘‘the extent and nature of illness and disability of the population of the United States.’’ This is an extension request for a generic approval from OMB to conduct customer surveys over the next three years at an overall burden rate of 4000 hours. As part of a comprehensive program, the National Center for Health Statistics (NCHS) plans to continue to assess its customers’ satisfaction with the content, quality and relevance of the information it produces. NCHS will conduct voluntary customer surveys to assess strengths in agency products and services and to evaluate how well it addresses the emerging needs of its data users. Results of these surveys will be used in future planning initiatives. The data will be collected using a combination of methodologies appropriate to each survey. These may include: evaluation forms, mail surveys, ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Questionnaire for conference registrants/attendees. Focus groups ............................. Web-based ................................. Other customer surveys ............. Total .................................... Number of respondents Form name Public/private and others. Public/private and others. Public/private and others. Public/private and others. 6,000 1 15/60 1,500 researchers, Consultants, 500 1 1 500 researchers, Consultants, 6,000 1 15/60 1,500 researchers, Consultants, 2,000 1 15/60 500 ................................................................. ........................ ........................ ........................ 4,000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jbell on DSKJLSW7X2PROD with NOTICES [FR Doc. 2020–06023 Filed 3–20–20; 8:45 am] [Docket No. FDA–2020–N–0008] BILLING CODE 4163–18–P Blood Products Advisory Committee; Postponed AGENCY: Food and Drug Administration, HHS. 17:26 Mar 20, 2020 Total burden (in hrs.) researchers, Consultants, Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. VerDate Sep<11>2014 Average burden per response (in hrs.) Number of responses per respondent Jkt 250001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 ACTION: Notice. The meeting of the Blood Products Advisory Committee (BPAC) scheduled for April 2–3, 2020, is postponed. The Food and Drug Administration (FDA), like other government agencies, is taking the necessary steps to ensure the Agency is prepared to continue our vital public health mission in the event that our dayto-day operations are impacted by the SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices COVID–19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Therefore, this meeting is being postponed. The meeting was announced in the Federal Register on February 13, 2020. FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993–0002, 240– 402–8054, christina.vert@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting, which was announced in the Federal Register of February 13, 2020, 85 FR 8299. Dated: March 18, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06082 Filed 3–20–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2020–N–0956] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Combination Products: How To Prepare a PreRequest for Designation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the type of information recommended for a PreRequest for Designation (Pre-RFD) submission. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:26 Mar 20, 2020 Jkt 250001 Submit either electronic or written comments on the collection of information by May 22, 2020. 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 May 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 22, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: 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’’). 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 submitte, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA 2020– N–0956 for ‘‘Combination Products: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 16369 How to Prepare a Pre-Request for Designation.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16368-16369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


Blood Products Advisory Committee; Postponed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Blood Products Advisory Committee (BPAC) 
scheduled for April 2-3, 2020, is postponed. The Food and Drug 
Administration (FDA), like other government agencies, is taking the 
necessary steps to ensure the Agency is prepared to continue our vital 
public health mission in the event that our day-to-day operations are 
impacted by the

[[Page 16369]]

COVID-19 public health emergency. Therefore, we are canceling or 
postponing all non-essential meetings through the month of April. We 
will reassess on an ongoing basis for future months. Therefore, this 
meeting is being postponed. The meeting was announced in the Federal 
Register on February 13, 2020.

FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), and follow the prompts to the desired center or product area. 
Please call the Information Line for up-to-date information on this 
meeting, which was announced in the Federal Register of February 13, 
2020, 85 FR 8299.

    Dated: March 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06082 Filed 3-20-20; 8:45 am]
 BILLING CODE 4164-01-P

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