83 FR 40522 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 158 (August 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 158 (August 15, 2018)
| Page Range | 40522-40524 | |
| FR Document | 2018-17524 |
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)] [Notices] [Pages 40522-40524] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17524] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2944] Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on September 20, 2018, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-2944. The docket will close on September 19, 2018. Submit either electronic or written comments on this public meeting by September 19, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 19, 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. Comments received on or before September 5, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: 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, [[Page 40523]] 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-2944 for ``Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' 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.'' FDA 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 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 the 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: Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting will focus on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge- Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the docket (see ADDRESSES) on or before September 5, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:40 a.m. to 11:10 a.m. and 3:20 p.m. to 3:50 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 28, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 29, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee [[Page 40524]] meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17524 Filed 8-14-18; 8:45 am] BILLING CODE 4164-01-P
![40522 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
of the FD&C Act (21 U.S.C. 379aa(b)(1)), of adverse drug experience reports approximately 283 respondents for
including followup reports under submitted for nonprescription drug nonprescription drugs marketed without
760(c)(2) of the FD&C Act (21 U.S.C. products marketed without an approved an approved application. We estimate
379aa(c)(2)), and how to submit these application and on prior input from that each submission will take
reports. The estimates for the annual comments received from prior Federal approximately 6 hours to prepare and
reporting and recordkeeping burdens Register publications. submit.
are based on FDA data on the number Based on FDA records, we received
194,449 total annual responses from
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Activity responses per annual burden per Total hours
respondents respondent responses response
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................ 283 687.099 194,449 6 1,166,694
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act (21 recommends that respondents maintain maintained by approximately 300
U.S.C. 379aa(e)) also requires that records of efforts to obtain the minimum respondents, and that it takes
responsible persons maintain records of data elements for a report of a serious approximately 8 hours to maintain each
nonprescription adverse event reports, adverse drug event and any followup record.
whether or not the event is serious, for reports. We estimate that there are
a period of 6 years. The guidance approximately 265,700 records per year
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of
Activity records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 300 885.6667 265,700 8 2,125,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the and Clinical Pharmacology Advisory www.regulations.gov electronic filing
information collection reflects an Committee. The general function of the system will accept comments until
overall increase. We attribute this committee is to provide advice and midnight Eastern Time at the end of
adjustment to an increase in the number recommendations to FDA on regulatory September 19, 2018. Comments received
of submissions we received in the last issues. The meeting will be open to the by mail/hand delivery/courier (for
few years. public. FDA is establishing a docket for written/paper submissions) will be
Dated: August 9, 2018. public comment on this document. considered timely if they are
Leslie Kux, DATES: The meeting will be held on postmarked or the delivery service
September 20, 2018, from 8 a.m. to 5 acceptance receipt is on or before that
Associate Commissioner for Policy.
p.m. date.
[FR Doc. 2018–17526 Filed 8–14–18; 8:45 am]
Comments received on or before
BILLING CODE 4164–01–P ADDRESSES: FDA White Oak Campus, September 5, 2018, will be provided to
10903 New Hampshire Ave., Bldg. 31 the committee. Comments received after
Conference Center, the Great Room (Rm. that date will be taken into
DEPARTMENT OF HEALTH AND 1503), Silver Spring, MD 20993–0002. consideration by FDA.
HUMAN SERVICES Answers to commonly asked questions You may submit comments as
including information regarding special follows:
Food and Drug Administration
accommodations due to a disability,
[Docket No. FDA–2018–N–2944] visitor parking, and transportation may Electronic Submissions
be accessed at: https://www.fda.gov/ Submit electronic comments in the
Pharmaceutical Science and Clinical AdvisoryCommittees/AboutAdvisory following way:
Pharmacology Advisory Committee; Committees/ucm408555.htm. • Federal eRulemaking Portal:
Notice of Meeting; Establishment of a FDA is establishing a docket for https://www.regulations.gov. Follow the
Public Docket; Request for Comments public comment on this meeting. The instructions for submitting comments.
AGENCY: Food and Drug Administration, docket number is FDA–2018–N–2944. Comments submitted electronically,
HHS. The docket will close on September 19, including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice; establishment of a 2018. Submit either electronic or www.regulations.gov will be posted to
public docket; request for comments. written comments on this public the docket unchanged. Because your
meeting by September 19, 2018. Please comment will be made public, you are
SUMMARY: The Food and Drug note that late, untimely filed comments solely responsible for ensuring that your
Administration (FDA) announces a will not be considered. Electronic comment does not include any
forthcoming public advisory committee comments must be submitted on or confidential information that you or a
meeting of the Pharmaceutical Science before September 19, 2018. The https:// third party may not wish to be posted,
VerDate Sep<11>2014 18:28 Aug 14, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\15AUN1.SGM 15AUN1](https://thefederalregister.org/doc/83_FR_40680/page/1.svg)
![40524 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
meetings. Please visit our website at the criteria for a priority review Electronic Submissions
https://www.fda.gov/Advisory voucher. CRYSVITA (burosamab-twza) Submit electronic comments in the
Committees/AboutAdvisoryCommittees/ is indicated for the treatment of X- following way:
ucm111462.htm for procedures on linked hypophosphatemia in adult and • Federal eRulemaking Portal:
public conduct during advisory pediatric patients 1 year of age and https://www.regulations.gov. Follow the
committee meetings. older. instructions for submitting comments.
Notice of this meeting is given under For further information about the Rare Comments submitted electronically,
the Federal Advisory Committee Act (5 Pediatric Disease Priority Review including attachments, to https://
U.S.C. app. 2). Voucher Program and for a link to the www.regulations.gov will be posted to
Dated: August 9, 2018. full text of section 529 of the FD&C Act, the docket unchanged. Because your
Leslie Kux, go to https://www.fda.gov/ForIndustry/ comment will be made public, you are
DevelopingProductsforRareDiseases solely responsible for ensuring that your
Associate Commissioner for Policy.
Conditions/RarePediatricDiseasePriority comment does not include any
[FR Doc. 2018–17524 Filed 8–14–18; 8:45 am]
VoucherProgram/default.htm. For confidential information that you or a
BILLING CODE 4164–01–P
further information about CRYSVITA third party may not wish to be posted,
(burosumab-twza), go to the ‘‘Drugs@ such as medical information, your or
FDA’’ website at https:// anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND
www.accessdata.fda.gov/scripts/cder/ confidential business information, such
HUMAN SERVICES
daf/. as a manufacturing process. Please note
Food and Drug Administration Dated: August 8, 2018. that if you include your name, contact
[Docket No. FDA–2017–N–0809] Leslie Kux, information, or other information that
Associate Commissioner for Policy. identifies you in the body of your
Issuance of Priority Review Voucher; [FR Doc. 2018–17527 Filed 8–14–18; 8:45 am] comments, that information will be
Rare Pediatric Disease Product BILLING CODE 4164–01–P posted on https://www.regulations.gov.
• If you want to submit a comment
AGENCY: Food and Drug Administration, with confidential information that you
HHS. do not wish to be made available to the
DEPARTMENT OF HEALTH AND
ACTION: Notice. HUMAN SERVICES public, submit the comment as a
SUMMARY: The Food and Drug written/paper submission and in the
Food and Drug Administration manner detailed (see ‘‘Written/Paper
Administration (FDA) is announcing the
issuance of a priority review voucher to [Docket No. FDA–2018–D–0943] Submissions’’ and ‘‘Instructions’’).
the sponsor of a rare pediatric disease Written/Paper Submissions
product application. The Federal Food, Elemental Impurities in Animal Drug
Products—Questions and Answers; Submit written/paper submissions as
Drug, and Cosmetic Act (FD&C Act), as
Draft Guidance for Industry; follows:
amended by the Food and Drug
Availability; Reopening of the • Mail/Hand delivery/Courier (for
Administration Safety and Innovation
Comment Period written/paper submissions): Dockets
Act (FDASIA), authorizes FDA to award
Management Staff (HFA–305), Food and
priority review vouchers to sponsors of AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
approved rare pediatric disease product HHS. Lane, Rm. 1061, Rockville, MD 20852.
applications that meet certain criteria.
ACTION: Notice of availability; reopening • For written/paper comments
FDA is required to publish notice of the
of the comment period. submitted to the Dockets Management
award of the priority review voucher.
Staff, FDA will post your comment, as
FDA has determined that CRYSVITA SUMMARY: The Food and Drug well as any attachments, except for
(burosamab-twza), manufactured by Administration (FDA or Agency) is information submitted, marked and
Ultragenyx Pharmaceutical, Inc., meets reopening the comment period for the identified, as confidential, if submitted
the criteria for a priority review notice of availability that published in as detailed in ‘‘Instructions.’’
voucher. the Federal Register on March 27, 2018. Instructions: All submissions received
FOR FURTHER INFORMATION CONTACT: In that document, FDA requested must include the Docket No. FDA–
Althea Cuff, Center for Drug Evaluation comments on the draft guidance for 2018–D–0943 for ‘‘Elemental Impurities
and Research, Food and Drug industry (GFI) #255 entitled ‘‘Elemental in Animal Drug Products—Questions
Administration, 10903 New Hampshire Impurities in Animal Drug Products— and Answers.’’ Received comments will
Ave., Silver Spring, MD 20993–0002, Questions and Answers.’’ The Agency is be placed in the docket and, except for
301–796–4061, Fax: 301–796–9856, taking this action in response to those submitted as ‘‘Confidential
email: althea.cuff@fda.hhs.gov. requests for an extension to allow Submissions,’’ publicly viewable at
SUPPLEMENTARY INFORMATION: FDA is interested parties additional time to https://www.regulations.gov or at the
announcing the issuance of a priority develop and submit comments. Dockets Management Staff between 9
review voucher to the sponsor of an DATES: FDA is reopening the comment a.m. and 4 p.m., Monday through
approved rare pediatric disease product period on the notice of availability Friday.
application. Under section 529 of the published March 27, 2018 (83 FR • Confidential Submissions—To
FD&C Act (21 U.S.C. 360ff), which was 13134). Submit either electronic or submit a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
added by FDASIA, FDA will award written comments on the draft guidance information that you do not wish to be
priority review vouchers to sponsors of by October 15, 2018 to ensure that the made publicly available, submit your
approved rare pediatric disease product Agency considers your comment on this comments only as a written/paper
applications that meet certain criteria. draft guidance before it begins work on submission. You should submit two
FDA has determined that CRYSVITA the final version of the guidance. copies total. One copy will include the
(burosamab-twza), manufactured by ADDRESSES: You may submit comments information you claim to be confidential
Ultragenyx Pharmaceutical, Inc., meets on any guidance at any time as follows: with a heading or cover note that states
VerDate Sep<11>2014 18:28 Aug 14, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15AUN1.SGM 15AUN1](https://thefederalregister.org/doc/83_FR_40680/page/3.svg)
Document Created: 2018-08-15 01:26:48
Document Modified: 2018-08-15 01:26:48
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on September 20, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 83 FR 40522 |
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