81 FR 43207 - Erythropoietic Protoporphyria; Scientific Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43207-43209 | |
| FR Document | 2016-15662 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43207-43209] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15662] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-N-2016-1493] Erythropoietic Protoporphyria; Scientific Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public workshop and an opportunity for public comment on Erythropoietic Protoporphyria (EPP). [[Page 43208]] The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for, and gain perspective from, patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion. DATES: The public workshop will be held on October 24, 2016, from 10 a.m. to 4 p.m. Submit electronic or written comments to the public docket by December 24, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter through Bldg. 1 and undergo security screening. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-N-2016-1493. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FDA will post the agenda approximately 5 days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm. FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Public Workshop Information A. Purpose and Scope of the Workshop FDA is announcing a public workshop and an opportunity for public comment on Erythropoietic Protoporphyria (EPP). EPP is a group of genetic disorders that is characterized by photosensitivity that often manifests as severe pain, swelling and/or burning. Treatment for EPP focuses on minimizing sun exposure. Other treatments may include dietary management, over-the-counter and prescription sunscreen, and phototherapy. The purpose of the workshop is to discuss issues that may affect the development of products for the treatments of EPP, and to provide a scientific and technical forum to consider issues related to clinical trial designs (including eligible populations and trial feasibility) and clinical trial endpoints. FDA will provide information on current review considerations for new products in the United States, and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on the most significant disease symptoms and its impact on daily life and experience with current treatment regimens for EPP. The input from this public workshop will help in developing topics for further discussion. B. Workshop Attendance and Participation Registration: If you wish to attend this workshop, visit https://eppscientificworkshop.eventbrite.com. Please register by October 17, 2016. If you are unable to attend the workshop in person, you can register to view a live Webcast of the workshop. You will be asked to [[Page 43209]] indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first- served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the workshop will be based on space availability. If you need special accommodations because of a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop. FDA will hold an open public comment period to give the public an opportunity to comment. Registration for open public comment will occur at the registration desk on the day of the workshop on a first-come, first-served basis. Docket Comments: Regardless of if you attend the public workshop, you can submit electronic or written responses for consideration to the public docket (see ADDRESSES) by December 24, 2016. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm. Dated: June 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15662 Filed 6-30-16; 8:45 am] BILLING CODE 4164-01-P
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Division of Dockets Management FOR FURTHER INFORMATION CONTACT: participation is not feasible or
between 9 a.m. and 4 p.m., Monday Jessica T. Walker, Center for Biologics appropriate. FDA notes that we already
through Friday. Evaluation and Research, Food and sought comments on the issues
• Confidential Submissions—To Drug Administration, 10903 New addressed by the revisions in this
submit a comment with confidential Hampshire Ave., Bldg. 71, Rm. 7301, guidance in the Federal Register of
information that you do not wish to be Silver Spring, MD 20993–0002, 240– March 31, 2015 under Docket No. FDA–
made publicly available, submit your 402–7911. 2010–D–0500. Further delay in
comments only as a written/paper SUPPLEMENTARY INFORMATION: implementing these revisions could
submission. You should submit two impede the progress of certain
I. Background investigations of drug use of
copies total. One copy will include the
FDA is announcing the availability of commercially marketed foods or dietary
information you claim to be confidential a document entitled ‘‘Early Clinical
with a heading or cover note that states supplements that are of low risk and
Trials With Live Biotherapeutic may be of benefit to the public health.
‘‘THIS DOCUMENT CONTAINS Products: Chemistry, Manufacturing, The guidance represents the current
CONFIDENTIAL INFORMATION.’’ The and Control Information; Guidance for thinking of FDA on ‘‘Early Clinical
Agency will review this copy, including Industry.’’ The guidance provides IND Trials with Live Biotherapeutic
the claimed confidential information, in sponsors with recommendations Products: Chemistry, Manufacturing,
its consideration of comments. The regarding IND submissions for early and Control Information.’’ It does not
second copy, which will have the clinical trials for LBPs in the United establish any rights for any person and
claimed confidential information States, including LBPs lawfully is not binding on FDA or the public.
redacted/blacked out, will be available marketed as conventional foods and You can use an alternative approach if
for public viewing and posted on http:// dietary supplements in the United it satisfies the requirements of the
www.regulations.gov. Submit both States and proposed for clinical uses applicable statutes and regulations.
copies to the Division of Dockets regulated under section 351 of the
Management. If you do not wish your Public Health Service (PHS) Act (42 II. Paperwork Reduction Act of 1995
name and contact information to be U.S.C. 262). The guidance focuses on The guidance refers to previously
made publicly available, you can the CMC information that should be approved collections of information
provide this information on the cover provided in an IND for early clinical found in FDA regulations. These
sheet and not in the body of your trials evaluating LBPs. The guidance is collections of information are subject to
comments and you must identify this applicable to INDs of LBPs, whether review by the Office of Management and
information as ‘‘confidential.’’ Any clinical trials are conducted Budget (OMB) under the Paperwork
information marked as ‘‘confidential’’ commercially, in an academic setting, or Reduction Act of 1995 (44 U.S.C. 3501–
will not be disclosed except in otherwise under part 312 (21 CFR part 3520). The collections of information in
accordance with 21 CFR 10.20 and other 312). part 312 have been approved under
applicable disclosure law. For more In the Federal Register of February OMB control number 0910–0014.
information about FDA’s posting of 21, 2012 (77 FR 9947), FDA announced
comments to public dockets, see 80 FR the availability of the final guidance of III. Electronic Access
56469, September 18, 2015, or access the same title dated February 2012. In Persons with access to the Internet
the information at: http://www.fda.gov/ the Federal Register of March 31, 2015 may obtain the guidance at either http://
regulatoryinformation/dockets/ (80 FR 17050), FDA published a notice www.fda.gov/BiologicsBloodVaccines/
default.htm. requesting additional comments on the GuidanceComplianceRegulatory
Docket: For access to the docket to CMC information that a sponsor of an Information/Guidances/default.htm or
read background documents or the IND should provide in its IND in order http://www.regulations.gov.
electronic and written/paper comments to meet regulatory requirements when Dated: June 27, 2016.
received, go to http:// commercially available conventional Leslie Kux,
www.regulations.gov and insert the foods or dietary supplements containing
Associate Commissioner for Policy.
docket number, found in brackets in the LBPs are used as investigational new
[FR Doc. 2016–15664 Filed 6–30–16; 8:45 am]
drugs in early phase clinical trials. FDA
heading of this document, into the BILLING CODE 4164–01–P
received a few comments on the notice
‘‘Search’’ box and follow the prompts
and in response to the comments, FDA
and/or go to the Division of Dockets
is updating the February 2012 guidance
Management, 5630 Fishers Lane, Rm. DEPARTMENT OF HEALTH AND
by adding a section to address when the
1061, Rockville, MD 20852. HUMAN SERVICES
label on commercially available
Submit written requests for single products will be considered adequate to Food and Drug Administration
copies of the guidance to the Office of satisfy the purpose of the CMC
Communication, Outreach and requirements for INDs under [Docket No. FDA–N–2016–1493]
Development, Center for Biologics § 312.23(a)(7)(iv)(a)–(b). In addition,
Evaluation and Research (CBER), Food editorial changes were made to improve Erythropoietic Protoporphyria;
and Drug Administration, 10903 New clarity. The guidance announced in this Scientific Workshop
Hampshire Ave., Bldg. 71, Rm. 3128, notice updates the guidance of the same AGENCY: Food and Drug Administration,
Silver Spring, MD 20993–0002. Send
asabaliauskas on DSK3SPTVN1PROD with NOTICES
title dated February 2012. HHS.
one self-addressed adhesive label to This guidance is being issued ACTION: Notice of public workshop;
assist the office in processing your consistent with FDA’s good guidance request for comments.
requests. The guidance may also be practices regulation (21 CFR 10.115).
obtained by mail by calling CBER at 1– FDA is issuing this guidance for SUMMARY: The Food and Drug
800–835–4709 or 240–402–8010. See immediate implementation in Administration (FDA or Agency) is
the SUPPLEMENTARY INFORMATION section accordance with 21 CFR 10.115(g)(2) announcing a public workshop and an
for electronic access to the guidance without seeking additional comments opportunity for public comment on
document. after determining that prior public Erythropoietic Protoporphyria (EPP).
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![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43209
indicate in your registration if you plan guidance on the design of Paliperidone Palmitate.’’ Received
to attend in person or via the Webcast. bioequivalence (BE) studies to support comments will be placed in the docket
Seating will be limited, so early abbreviated new drug applications and, except for those submitted as
registration is recommended. (ANDAs) for paliperidone palmitate ‘‘Confidential Submissions,’’ publicly
Registration is free and will be on a first- extended-release injectable suspension. viewable at http://www.regulations.gov
come, first-served basis. However, FDA DATES: Although you can comment on or at the Division of Dockets
may limit the number of participants any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
from each organization based on space 10.115(g)(5)), to ensure that the Agency Monday through Friday.
limitations. Registrants will receive considers your comment on this draft • Confidential Submissions—To
confirmation once they have been guidance before it begins work on the submit a comment with confidential
accepted. Onsite registration on the day final version of the guidance, submit information that you do not wish to be
of the workshop will be based on space either electronic or written comments made publicly available, submit your
availability. If you need special on the draft guidance by September 6, comments only as a written/paper
accommodations because of a disability, 2016. submission. You should submit two
please contact Meghana Chalasani (see ADDRESSES: You may submit comments copies total. One copy will include the
FOR FURTHER INFORMATION CONTACT) at information you claim to be confidential
as follows:
least 7 days before the workshop. with a heading or cover note that states
FDA will hold an open public Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
comment period to give the public an Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
opportunity to comment. Registration following way: Agency will review this copy, including
for open public comment will occur at • Federal eRulemaking Portal: http:// the claimed confidential information, in
the registration desk on the day of the www.regulations.gov. Follow the its consideration of comments. The
workshop on a first-come, first-served instructions for submitting comments. second copy, which will have the
basis. Comments submitted electronically, claimed confidential information
Docket Comments: Regardless of if including attachments, to http:// redacted/blacked out, will be available
you attend the public workshop, you www.regulations.gov will be posted to for public viewing and posted on http://
can submit electronic or written the docket unchanged. Because your www.regulations.gov. Submit both
responses for consideration to the comment will be made public, you are copies to the Division of Dockets
public docket (see ADDRESSES) by solely responsible for ensuring that your Management. If you do not wish your
December 24, 2016. Received comments comment does not include any name and contact information to be
may be seen in the Division of Dockets confidential information that you or a made publicly available, you can
Management between 9 a.m. and 4 p.m., third party may not wish to be posted, provide this information on the cover
Monday through Friday, and will be such as medical information, your or sheet and not in the body of your
posted to the docket at http:// anyone else’s Social Security number, or comments and you must identify this
www.regulations.gov. confidential business information, such information as ‘‘confidential.’’ Any
Transcripts: As soon as a transcript is as a manufacturing process. Please note information marked as ‘‘confidential’’
available, FDA will post it at http:// that if you include your name, contact will not be disclosed except in
www.fda.gov/Drugs/NewsEvents/ information, or other information that accordance with 21 CFR 10.20 and other
ucm501389.htm. identifies you in the body of your applicable disclosure law. For more
Dated: June 27, 2016. comments, that information will be information about FDA’s posting of
Leslie Kux, posted on http://www.regulations.gov. comments to public dockets, see 80 FR
Associate Commissioner for Policy. • If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
[FR Doc. 2016–15662 Filed 6–30–16; 8:45 am]
do not wish to be made available to the regulatoryinformation/dockets/
BILLING CODE 4164–01–P
public, submit the comment as a default.htm.
written/paper submission and in the Docket: For access to the docket to
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper read background documents or the
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://www.regulations.
Written/Paper Submissions gov and insert the docket number, found
Food and Drug Administration
Submit written/paper submissions as in brackets in the heading of this
[Docket No. FDA–2007–D–0369] follows: document, into the ‘‘Search’’ box and
• Mail/Hand delivery/Courier (for follow the prompts and/or go to the
Bioequivalence Recommendations for
written/paper submissions): Division of Division of Dockets Management, 5630
Paliperidone Palmitate; Draft Guidance
Dockets Management (HFA–305), Food Fishers Lane, Rm. 1061, Rockville, MD
for Industry; Availability
and Drug Administration, 5630 Fishers 20852.
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single
HHS. • For written/paper comments copies of the draft guidance to the
ACTION: Notice of availability. submitted to the Division of Dockets Division of Drug Information, Center for
Management, FDA will post your Drug Evaluation and Research, Food
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY: The Food and Drug comment, as well as any attachments, and Drug Administration, 10001 New
Administration (FDA) is announcing the except for information submitted, Hampshire Ave., Hillandale Building,
availability of a revised draft guidance marked and identified, as confidential, 4th Floor, Silver Spring, MD 20993–
for industry on generic paliperidone if submitted as detailed in 0002. Send one self-addressed adhesive
palmitate extended-release injectable ‘‘Instructions.’’ label to assist that office in processing
suspension, entitled ‘‘Draft Guidance on Instructions: All submissions received your requests. See the SUPPLEMENTARY
Paliperidone Palmitate.’’ The must include the Docket No. FDA– INFORMATION section for electronic
recommendations provide specific 2007–D–0369 for ‘‘Draft Guidance on access to the draft guidance document.
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Document Created: 2016-07-14 11:37:21
Document Modified: 2016-07-14 11:37:21
| 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 October 24, 2016, from 10 a.m. to 4 p.m. Submit electronic or written comments to the public docket by December 24, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected] | |
| FR Citation | 81 FR 43207 |
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