Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Extension of Comment Period, 28822-28823 [2019-13122]

Download as PDF 28822 Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Form name PCNASP Awardee .......................................... — Hospital inventory ........................................... In-hospital care data ...................................... Pre-hospital care data .................................... 7 Post-hospital transition of care data .............. 2 Hospital Inventory .......................................... PCNASP Hospital Partners ............................ Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–13054 Filed 6–19–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1482] Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of April 3, 2019. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. We are extending the comment period to give interested parties more time to comment. DATES: FDA is extending the comment period on the notice published in the Federal Register of April 3, 2019 (84 FR 12969). Submit either electronic or written comments by July 16, 2019. 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 July 16, 2019. The https://www.regulations.gov electronic filing system will accept SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Number of respondents Type of respondents VerDate Sep<11>2014 17:47 Jun 19, 2019 Jkt 247001 comments until 11:59 p.m. Eastern Time at the end of July 16, 2019. 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. 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 submitted, marked and PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 9 9 2 4 7 4 378 Number of responses per respondent 1 4 4 2 4 1 1 Average burden per response (in hours) 8 30/60 30/60 30/60 30/60 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–N–1482 for ‘‘Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.’’ 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.’’ We will review this copy, including the claimed confidential information, in our 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the E:\FR\FM\20JNN1.SGM 20JNN1 Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Notices 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: April Alexandrow, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Room 3147, Silver Spring, MD 20993, 301–796–5363. In the Federal Register of April 3, 2019, FDA published a notice announcing a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, we notified the public that FDA was establishing a docket for public comment on this hearing. The information from the hearing and comments provided to the docket will inform our regulatory oversight of these products and is an important step in our continued evaluation of cannabis and cannabisderived compounds in FDA-regulated products. We asked that comments be submitted by July 2, 2019. At the public hearing, we received requests for a 30-day extension of the comment period for the notice. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to the questions that appeared in the notice requesting data and other evidence in support of answers. We have considered the requests and are extending the comment period for another 14 days, until July 16, 2019. We believe that a 14-day extension allows adequate time for interested persons to submit comments without significantly delaying any potential further action on these important issues. SUPPLEMENTARY INFORMATION: Dated: June 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–13122 Filed 6–19–19; 8:45 am] jbell on DSK3GLQ082PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Privacy Act of 1974; System of Records Department of Health and Human Services. AGENCY: VerDate Sep<11>2014 17:47 Jun 19, 2019 Jkt 247001 Notice of a new system of records, and rescindment of related systems. ACTION: In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new department-wide system of records, titled HHS Correspondence, Customer Service, and Contact List Records, system no. 09–90–1901. The new system of records replaces 13 existing systems of records which are rescinded in this notice, and it includes additional records not currently covered by any SORN. Two other related systems of records are also rescinded in this notice, but not replaced by the new SORN, because those records no longer exist. DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this notice is applicable June 20, 2019, subject to a 30-day period in which to comment on the routine uses, described below. Please submit any comments by July 22, 2019. ADDRESSES: The public should submit written comments on this notice, by mail or email, to Beth Kramer, HHS Privacy Act Officer, 200 Independence Ave. SW, Suite 729H, Washington, DC 20201, or beth.kramer@hhs.gov. Comments will be available for public viewing at the same location. To review comments in person, please contact Beth Kramer at beth.kramer@hhs.gov or 202–690–6941. FOR FURTHER INFORMATION CONTACT: General questions may be submitted to Beth Kramer, HHS Privacy Act Officer, at 200 Independence Ave. SW, Suite 729H, Washington, DC 20201, or beth.kramer@hhs.gov, or 202–690–6941. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background on New SORN 09–90– 1901 HHS is establishing this new department-wide system of records to cover records about individuals within or outside HHS which are retrieved by personal identifier and used in managing HHS correspondence and customer service functions, including help desk and call center activities, dissemination of publications, studies, opinions, unrestricted datasets, and other information, and mailing and contact lists, unless covered by a more specific system of records notice (SORN). It will include the records currently covered in 13 related SORNs, in order to replace and rescind those SORNs, but with revisions where needed to provide updated descriptions of those records. It will also include other functionally similar records not PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 28823 currently covered by any SORN. The up-to-date records descriptions used in the new SORN differ from the descriptions used in the replaced SORNs in these respects: • The System Manager contact information has been updated and is grouped by record type. • The System Location section refers to the contact information shown in the System Manager section. • The Authorities section now cites 5 U.S.C. 301, 305; 21 U.S.C. 301 et seq.; 31 U.S.C. 1115(b)(6); 40 U.S.C. 11313; 42 U.S.C. 201 et seq.; 44 U.S.C. 3101; E.O. 11583; and E.O. 13571. This differs from the authorities cited in each replaced SORN as follows: a. OS SORNs 09–37–0001, 09–90– 0027, 09–90–0037, 09–90–0038, and 09– 90–0072 and HRSA SORN 09–15–0059 cited only one of the authorities cited in the new SORN, 5 U.S.C. 301. b. NIH SORN 09–25–0106 cited two authorities cited in the new SORN, 5 U.S.C. 301 and 44 U.S.C. 3101. c. OS SORN 09–90–0001 cited 5 U.S.C. 301 and one authority not cited in the new SORN: 40 U.S.C. 486(c). d. FDA SORN 09–10–0004 cited 42 U.S.C. 201 et seq., which is cited in the new SORN, and two authorities not cited in the new SORN: 21 U.S.C. 321 et seq. and 21 CFR part 5. e. SAMHSA SORN 09–30–0033 cited portions of title 42 of the United States Code, which is cited in the new SORN, and these authorities not cited in the new SORN: 8 U.S.C. 1522 note, as amended by sec. 501(c) of Public Law 96–422; E.O. 12341; and sec. 413 of Public Law 93–288 as amended and redesignated as sec. 416 by Public Law 100–107 [sic; probably should be Public Law 101–707, amending 42 U.S.C. 5183]. f. These SORNs cited none of the authorities cited in the new SORN: i. OS SORN 09–90–0161 cited 42 U.S.C. 300u-6; ii. CDC SORN 09–20–0059 cited 29 U.S.C. 670; iii. CMS SORN 09–70–3005 cited 42 U.S.C. 1306(a) and 42 CFR 401.101– 401.148; and iv. SAMHSA SORN 09–30–0051 cited sec. 501 of the Public Health Service Act (42 U.S.C. 290a) as amended by Public Law 102–321 and Public Law 106–310. • The new SORN provides broader and more detailed descriptions of the categories of records and the purposes for which the records are used than were in each replaced SORN, in recognition that some of the records interrelate with each other and may be maintained and used together, and by more than one office, to achieve certain purposes. Each replaced SORN E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28822-28823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13122]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1482]


Scientific Data and Information About Products Containing 
Cannabis or Cannabis-Derived Compounds; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice that appeared in the Federal Register of 
April 3, 2019. The notice announced a public hearing to obtain 
scientific data and information about the safety, manufacturing, 
product quality, marketing, labeling, and sale of products containing 
cannabis or cannabis-derived compounds. In addition, it notified the 
public that FDA was establishing a docket for public comment on this 
hearing and that the docket would close on July 2, 2019. We are 
extending the comment period to give interested parties more time to 
comment.

DATES: FDA is extending the comment period on the notice published in 
the Federal Register of April 3, 2019 (84 FR 12969). Submit either 
electronic or written comments by July 16, 2019.

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 July 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 16, 2019. 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.

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 submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-1482 for ``Scientific Data and Information About Products 
Containing Cannabis or Cannabis-Derived Compounds.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the

[[Page 28823]]

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: April Alexandrow, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Room 3147, Silver 
Spring, MD 20993, 301-796-5363.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 3, 2019, 
FDA published a notice announcing a public hearing to obtain scientific 
data and information about the safety, manufacturing, product quality, 
marketing, labeling, and sale of products containing cannabis or 
cannabis-derived compounds. In addition, we notified the public that 
FDA was establishing a docket for public comment on this hearing. The 
information from the hearing and comments provided to the docket will 
inform our regulatory oversight of these products and is an important 
step in our continued evaluation of cannabis and cannabis-derived 
compounds in FDA-regulated products. We asked that comments be 
submitted by July 2, 2019.
    At the public hearing, we received requests for a 30-day extension 
of the comment period for the notice. The requests conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop meaningful or thoughtful responses to the questions that 
appeared in the notice requesting data and other evidence in support of 
answers.
    We have considered the requests and are extending the comment 
period for another 14 days, until July 16, 2019. We believe that a 14-
day extension allows adequate time for interested persons to submit 
comments without significantly delaying any potential further action on 
these important issues.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13122 Filed 6-19-19; 8:45 am]
 BILLING CODE 4164-01-P
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