83 FR 30742 - Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 126 (June 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30742-30744 | |
| FR Document | 2018-14048 |
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)] [Notices] [Pages 30742-30744] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14048] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2398] Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy. DATES: The public workshop will be held on August 21, 2018, from 8:30 a.m. to 4:30 p.m. and August 22, 2018, from [[Page 30743]] 8:30 a.m. to 12 noon. Submit either electronic or written comments on this public workshop by August 15, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 August 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight eastern time on August 15, 2018. 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-2018-N-2398 for ``Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop.'' 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/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: 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop regarding development of non- traditional therapies for bacterial infections. Discussions will focus on pre-clinical development, early stage clinical trials, and phase 3 clinical trial designs to evaluate safety and efficacy of non- traditional therapies intended to serve as primary or adjunctive therapy to existing antibacterial drugs. II. Topics for Discussion at the Public Workshop FDA is particularly interested in discussing pre-clinical and clinical development of several types of non-traditional therapies, including monoclonal antibodies, immunomodulators, lysins, and other non-traditional therapies. The Agency encourages health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders to attend this public workshop. III. Participating in the Public Workshop Registration: Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register online by August 14, 2018, midnight Eastern Time. To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to [email protected]. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. [[Page 30744]] If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) no later than August 13, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations or request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by August 10, 2018. All requests to make oral presentations must be received by the close of registration on August 6, 2018. If selected for presentation, any presentation materials must be emailed to [email protected] no later than August 14, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be webcast at the following site: https://collaboration.fda.gov/dcontpfbi/. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm606052.htm. Dated: June 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14048 Filed 6-28-18; 8:45 am] BILLING CODE 4164-01-P
![30742 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
collection of information to OMB for about the foods they purchase for their (Response) We based our estimate of
review and clearance. animals. Color additive information the number of respondents on the
enables a consumer to comparison shop number of pet food manufacturers
Animal Food Labeling; Declaration of
and to avoid substances to which their subject to this regulation. The figure of
Certifiable Color Additives
animals may be sensitive. 3,120 used in table 1 was derived from
OMB Control Number 0910–0721— Description of Respondents: the number of establishments listed
Extension Respondents to this collection of under North American Industrial
information are manufacturers of pet Classification System codes 311111 and
This information collection is food products that contain color
associated with requirements under 311119, including very small
additives. In the Federal Register of
§ 501.22(k) (21 CFR 501.22(k)) in which establishments. As noted in the 60-day
February 20, 2018 (83 FR 7198), FDA
animal food manufacturers must declare published a 60-day notice requesting notice, we based our estimate of the
the presence of certified and public comment on the proposed flow of new products on A.C. Nielsen
noncertified color additives in their collection of information. data for the number of animal food
animal food products on the product (Comment) One comment was product units for sale (for which sales
label. We issued this regulation in received that supported FDA’s need for of the products are greater than zero) in
response to the Nutrition Labeling and the information collection and the latest year for which data is
Education Act of 1990 (Pub. L. 101–535) characterized the burden of the available, stated to be 25,874. Then, we
to make animal food regulations information collection as low compared assumed that the flow of new products
consistent with the regulations to the importance of informative food would be 10 percent per year, for a
regarding the declaration of color labels. The comment did not suggest figure of 2,587 new products per year.
additives on human food labels and to revising our estimate of the burden. That figure was used in table 1 as our
provide animal owners with However, it suggested we should estimate of the total annual disclosures.
information on the color additives used provide greater detail about how we FDA estimates the burden of this
in animal food. Animal owners use the estimated the number of respondents collection of information as follows:
information to become knowledgeable and the flow of new products.
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR Section/activity disclosures per Total hours
respondents disclosures disclosure
respondent
501.22(k); labeling of color additive or 3,120 0.8292 2,587 0.25 (15 minutes) ...... 647
lake of color additive; labeling of color
additives not subject to certification.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The requirement became effective firms prepare the required labeling for DEPARTMENT OF HEALTH AND
November 18, 2013; thus, we estimate their products in a manner that takes HUMAN SERVICES
that the burden associated with the into account at one time all information
labeling requirements under § 501.22(k) required to be disclosed on their Food and Drug Administration
applies only to new product labels. product labels. Based on our experience [Docket No. FDA–2018–N–2398]
Because the vast majority of animal food with reviewing pet food labeling, we
products that contain certified color estimate that firms would require less Development of Non-Traditional
additives are pet foods, we limit our than 0.25 hour (15 minutes) per product Therapies for Bacterial Infections;
burden estimate to reviewing labels for to comply with the requirement to Public Workshop; Request for
the use of certified color additives to pet include the color additive information Comments
food manufacturers subject to this pursuant to § 501.22(k). The total AGENCY: Food and Drug Administration,
regulation. Based on A.C. Nielsen data, burden of this activity is 647 hours HHS.
we estimate that the number of animal (2,587 labels × 0.25 hour/label is ACTION: Notice of public workshop;
food product units subject to § 501.22(k) approximately 647 hours). The burden request for comments.
for which sales of the products are for this information collection has not
greater than zero is 25,874. Assuming changed since the last OMB approval. SUMMARY: The Food and Drug
that the flow of new products is 10 Administration (FDA, the Agency, or
percent per year, then 2,587 new animal Dated: June 26, 2018. we) is announcing the following public
food products subject to § 501.22(k) will Leslie Kux, workshop entitled ‘‘Development of
become available on the market each Associate Commissioner for Policy. Non-Traditional Therapies for Bacterial
year. We also estimate that there are [FR Doc. 2018–14059 Filed 6–28–18; 8:45 am] Infections.’’ The purpose of the public
approximately 3,120 manufacturers of BILLING CODE 4164–01–P workshop is to discuss the general
pet food subject to either § 501.22(k)(1) development considerations of non-
sradovich on DSK3GMQ082PROD with NOTICES
or (2). Assuming the approximately traditional therapies, including pre-
2,587 new products are split equally clinical development, early clinical
among the firms, then each firm would studies, and phase 3 clinical trial
prepare labels for approximately 0.8292 designs to evaluate safety and efficacy.
new products per year (2,587 new DATES: The public workshop will be
products—3,120 firms is approximately held on August 21, 2018, from 8:30 a.m.
0.8292 labels per firm). We expect that to 4:30 p.m. and August 22, 2018, from
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![30744 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
If you need special accommodations DEPARTMENT OF HEALTH AND • Mail/Hand Delivery/Courier (for
due to a disability, please contact Jessica HUMAN SERVICES written/paper submissions): Dockets
Barnes or Lori Benner (see FOR FURTHER Management Staff (HFA–305), Food and
INFORMATION CONTACT) no later than Food and Drug Administration Drug Administration, 5630 Fishers
August 13, 2018. [Docket No. FDA–2017–D–6209] Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
Requests for Oral Presentations:
Assessing User Fees Under the submitted to the Dockets Management
During online registration you may Staff, FDA will post your comment, as
indicate if you wish to present during a Biosimilar User Fee Amendments of
2017; Guidance for Industry; well as any attachments, except for
public comment session or participate information submitted, marked and
in a specific session, and which topic(s) Availability
identified, as confidential, if submitted
you wish to address. We will do our AGENCY: Food and Drug Administration, as detailed in ‘‘Instructions.’’
best to accommodate requests to make HHS. Instructions: All submissions received
public comments. Individuals and ACTION: Notice of availability. must include the Docket No. FDA–
organizations with common interests are 2017–D–6209 for ‘‘Assessing User Fees
urged to consolidate or coordinate their SUMMARY: The Food and Drug Under the Biosimilar User Fee
presentations or request time for a joint Administration (FDA or Agency) is Amendments of 2017.’’ Received
presentation. Following the close of announcing the availability of a final comments will be placed in the docket
registration, we will determine the guidance for industry entitled and, except for those submitted as
amount of time allotted to each ‘‘Assessing User Fees Under the ‘‘Confidential Submissions,’’ publicly
presenter and the approximate time Biosimilar User Fee Amendments of viewable at https://www.regulations.gov
each oral presentation is to begin, and 2017.’’ This guidance concerns FDA’s or at the Dockets Management Staff
will select and notify participants by implementation of the Biosimilar User between 9 a.m. and 4 p.m., Monday
August 10, 2018. All requests to make Fee Amendments of 2017 (BsUFA II) through Friday.
oral presentations must be received by and certain changes in policies and • Confidential Submissions—To
the close of registration on August 6, procedures surrounding its application. submit a comment with confidential
2018. If selected for presentation, any DATES: The announcement of the information that you do not wish to be
presentation materials must be emailed guidance is published in the Federal made publicly available, submit your
to NonTraditionalTherapiesWorkshop Register on June 29, 2018. comments only as a written/paper
2018@fda.hhs.gov no later than August ADDRESSES: You may submit either submission. You should submit two
14, 2018. No commercial or promotional electronic or written comments on copies total. One copy will include the
material will be permitted to be Agency guidances at any time as information you claim to be confidential
presented or distributed at the public follows: with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
workshop. Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Streaming Webcast of the Public Submit electronic comments in the Agency will review this copy, including
Workshop: This public workshop will following way: the claimed confidential information, in
also be webcast at the following site: • Federal eRulemaking Portal: its consideration of comments. The
https://collaboration.fda.gov/dcontpfbi/. https://www.regulations.gov. Follow the second copy, which will have the
If you have never attended a Connect instructions for submitting comments. claimed confidential information
Pro event before, test your connection at Comments submitted electronically, redacted/blacked out, will be available
https://collaboration.fda.gov/common/ including attachments, to https:// for public viewing and posted on
help/en/support/meeting_test.htm. To www.regulations.gov will be posted to https://www.regulations.gov. Submit
get a quick overview of the Connect Pro the docket unchanged. Because your both copies to the Dockets Management
program, visit https://www.adobe.com/ comment will be made public, you are Staff. If you do not wish your name and
go/connectpro_overview. FDA has solely responsible for ensuring that your contact information to be made publicly
verified the website addresses in this comment does not include any available, you can provide this
document, as of the date this document confidential information that you or a information on the cover sheet and not
publishes in the Federal Register, but third party may not wish to be posted, in the body of your comments and you
websites are subject to change over time. such as medical information, your or must identify this information as
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Transcripts: Please be advised that as confidential business information, such as ‘‘confidential’’ will not be disclosed
soon as a transcript of the public as a manufacturing process. Please note except in accordance with 21 CFR 10.20
workshop is available, it will be that if you include your name, contact and other applicable disclosure law. For
accessible at https:// information, or other information that more information about FDA’s posting
www.regulations.gov. It may be viewed identifies you in the body of your of comments to public dockets, see 80
at the Dockets Management Staff (HFA– comments, that information will be FR 56469, September 18, 2015, or access
305), Food and Drug Administration, posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
5630 Fishers Lane, Rm. 1061, Rockville, • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
MD 20852. A link to the transcript will with confidential information that you 23389.pdf.
also be available on the internet at do not wish to be made available to the Docket: For access to the docket to
https://www.fda.gov/Drugs/NewsEvents/ read background documents or the
sradovich on DSK3GMQ082PROD with NOTICES
public, submit the comment as a
ucm606052.htm. written/paper submission and in the electronic and written/paper comments
Dated: June 26, 2018. manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Leslie Kux,
docket number, found in brackets in the
Associate Commissioner for Policy. Written/Paper Submissions heading of this document, into the
[FR Doc. 2018–14048 Filed 6–28–18; 8:45 am] Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
BILLING CODE 4164–01–P follows: and/or go to the Dockets Management
VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1](https://thefederalregister.org/doc/83_FR_30868/page/3.svg)
Document Created: 2018-06-29 01:13:43
Document Modified: 2018-06-29 01:13:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| Dates | The public workshop will be held on August 21, 2018, from 8:30 a.m. to 4:30 p.m. and August 22, 2018, from 8:30 a.m. to 12 noon. Submit either electronic or written comments on this public workshop by August 15, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and 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. | |
| FR Citation | 83 FR 30742 |
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