Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients; Public Workshop; Cancellation, 33267 [2019-14887]

Download as PDF Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authorities: Section 466(a)(19) of the Social Security Act (42 U.S.C. 666(a)(19)), section 609(a)(5)(C) of the Employee Retirement Income Security Act of 1974 (ERISA) (29 U.S.C. 1169(a)(5)(C)), and for State and local government and church plans sections 401(e) and (f) of the Child Support Performance and Incentive Act of 1998 (29 CFR 2590.609–2). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–14834 Filed 7–11–19; 8:45 am] BILLING CODE 4184–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1346] Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients; Public Workshop; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration is announcing the cancellation of a public workshop entitled ‘‘Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients’’ that was previously scheduled for August 8, 2019, from 8:30 a.m. to 4:30 p.m. This public workshop was announced in the Federal Register of May 2, 2019. The meeting has been cancelled due to unforeseen changes in the adenovirus drug development landscape. SUMMARY: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993–0002, 301– 796–1300, about this public workshop, which was announced in the Federal Register of May 2, 2019 (84 FR 18848). jbell on DSK3GLQ082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 16:55 Jul 11, 2019 Jkt 247001 Dated: July 8, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14887 Filed 7–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–2398] Population Pharmacokinetics; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Population Pharmacokinetics.’’ This revised draft guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA’s current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs) and biologic license applications (BLAs). The revised draft guidance also provides expectations regarding the format and content of the population PK report as well as any labeling recommendations resulting from such analyses. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 10, 2019. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 33267 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–2398 for ‘‘Population Pharmacokinetics.’’ 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 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Page 33267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1346]


Development of Antiviral Drugs for the Treatment of Adenoviral 
Infection in Immunocompromised Patients; Public Workshop; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration is announcing the 
cancellation of a public workshop entitled ``Development of Antiviral 
Drugs for the Treatment of Adenoviral Infection in Immunocompromised 
Patients'' that was previously scheduled for August 8, 2019, from 8:30 
a.m. to 4:30 p.m. This public workshop was announced in the Federal 
Register of May 2, 2019. The meeting has been cancelled due to 
unforeseen changes in the adenovirus drug development landscape.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002, 301-796-1300, about this public workshop, which was announced in 
the Federal Register of May 2, 2019 (84 FR 18848).

    Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14887 Filed 7-11-19; 8:45 am]
BILLING CODE 4164-01-P

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