83 FR 2794 - Gastrointestinal Drugs 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 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2794-2796 | |
| FR Document | 2018-00903 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2794-2796] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00903] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0055] Gastrointestinal Drugs 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 Gastrointestinal Drugs 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 [[Page 2795]] a docket for public comment on this document. DATES: The meeting will be held on March 8, 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-0055. The docket will close on March 7, 2018. Submit either electronic or written comments on this public meeting by March 7, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 7, 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 February 22, 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, 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-0055 for ``Gastrointestinal Drugs 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: [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 the 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 committee will discuss supplemental new drug application (sNDA) 203214 supplement 18, XELJANZ (tofacitinib) tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy. 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 [[Page 2796]] appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 7, 2018. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 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 February 13, 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 February 14, 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 [email protected] 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 R. 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 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: January 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00903 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
![2794 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
compounder has the option of not filling should be maintained; and when such disclosures’’ in table 1, line 1). We
a prescription with a compounded drug records should be presented to FDA. estimate that the consultation between
if a prescriber determination is not FDA Response to Issue Six: FDA has the compounder and the prescriber and
provided. revised the guidance to include a adding a notation to each prescription
Issue Five: One commenter stated that recommended duration of 3 years for that does not already document this
requiring a notation on the prescription maintaining records. The guidance determination will take approximately 3
that a compounded drug was on the describes the records that can be minutes per prescription order.
drug shortage list when compounded, retained to demonstrate compliance. In addition, we estimate that a total of
and the date the list was checked, FDA may request to review such records approximately 6,888 compounders
would be overly burdensome. during establishment inspections. (‘‘number of respondents’’ in table 1,
FDA Response to Issue Five: FDA FDA estimates the burden of this line 2) will document this information
does not believe this presents a collection of information as follows: on approximately 344,400 prescription
significant burden, as a compounder We estimate that annually a total of orders for compounded drugs (‘‘total
that wants to rely on a drug shortage to approximately 6,888 compounders annual disclosures’’ in table 1, line 2).
establish that a compounded drug is not (‘‘number of respondents’’ in table 1, We estimate that checking FDA’s drug
essentially a copy of a commercially line 1) will consult a prescriber to shortage list and documenting this
available drug would need to check determine whether he or she has made information will take approximately 2
FDA’s shortage website. Noting the date a determination that the compounded minutes per prescription order.
the list was checked is not onerous, and drug has a change that produces a We estimate that a total of
is necessary for FDA to verify significant difference for a patient as approximately 3,444 compounders
compliance during inspections. FDA compared to the comparable (‘‘number of recordkeepers’’ in table 2)
estimates this activity would take 2 commercially available drug, and that will keep approximately 165,312
minutes. the compounders will document this records (‘‘total annual records’’). We
Issue Six: One commenter requested determination on approximately estimate that maintaining the records
clarity on how long records should be 172,200 prescription orders for will take approximately 2 minutes per
maintained; what specific information compounded drugs (‘‘total annual record.
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden per
Type of reporting Total hours
respondents per disclosures disclosure
respondent
Consultation between the compounder and pre- 6,888 50 344,400 0.05 (3 minutes) ....... 17,220
scriber and the notation on the prescription docu-
menting the prescriber’s determination of signifi-
cant difference.
Checking FDA’s drug shortage list and docu- 6,888 50 344,400 0.03 (2 minutes) ....... 10,332
menting on the prescription that the drug is in
shortage.
Total ................................................................... ........................ ........................ ........................ ................................... 27,552
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden per
Type of recordkeeping records per Total hours
recordkeepers records recordkeeping
recordkeeper
Records of frequency and number of prescriptions 3,444 48 165,312 0.03 (2 minutes) ....... 4,959
filled for compounded drugs that are essentially a
copy.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice; establishment of a
Leslie Kux, HUMAN SERVICES public docket; request for comments.
Associate Commissioner for Policy.
Food and Drug Administration SUMMARY: The Food and Drug
[FR Doc. 2018–00917 Filed 1–18–18; 8:45 am]
BILLING CODE 4164–01–P
Administration (FDA) announces a
[Docket No. FDA–2018–N–0055] forthcoming public advisory committee
daltland on DSKBBV9HB2PROD with NOTICES
meeting of the Gastrointestinal Drugs
Gastrointestinal Drugs Advisory
Advisory Committee. The general
Committee; Notice of Meeting;
function of the committee is to provide
Establishment of a Public Docket;
advice and recommendations to FDA on
Request for Comments
regulatory issues. The meeting will be
AGENCY: Food and Drug Administration, open to the public. FDA is establishing
HHS.
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![2796 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND comments, that information will be
link. HUMAN SERVICES posted on https://www.regulations.gov.
Procedure: Interested persons may • If you want to submit a comment
Food and Drug Administration with confidential information that you
present data, information, or views,
do not wish to be made available to the
orally or in writing, on issues pending [Docket No. FDA–2017–D–6969] public, submit the comment as a
before the committee. Written written/paper submission and in the
submissions may be made to the contact Product Title and Initial U.S. Approval
manner detailed (see ‘‘Written/Paper
person on or before March 7, 2018. Oral in Highlights for Human Prescription
Submissions’’ and ‘‘Instructions’’).
presentations from the public will be Drug and Biological Products—
scheduled between approximately 12:40 Content and Format; Draft Guidance Written/Paper Submissions
p.m. and 1:40 p.m. Those individuals for Industry; Availability Submit written/paper submissions as
interested in making formal oral AGENCY: Food and Drug Administration, follows:
presentations should notify the contact HHS. • Mail/Hand delivery/Courier (for
person and submit a brief statement of written/paper submissions): Dockets
ACTION: Notice of availability. Management Staff (HFA–305), Food and
the general nature of the evidence or
arguments they wish to present, the SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
names and addresses of proposed Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
participants, and an indication of the • For written/paper comments
announcing the availability of a draft
approximate time requested to make submitted to the Dockets Management
guidance for industry entitled ‘‘Product
their presentation on or before February Staff, FDA will post your comment, as
Title and Initial U.S. Approval in the
well as any attachments, except for
13, 2018. Time allotted for each Highlights of Prescribing Information for
information submitted, marked and
presentation may be limited. If the Human Prescription Drug and Biological
identified, as confidential, if submitted
number of registrants requesting to Products—Content and Format.’’ The
as detailed in ‘‘Instructions.’’
speak is greater than can be reasonably labeling regulations for human drug and Instructions: All submissions received
accommodated during the scheduled biological products require that the must include the Docket No. FDA–
open public hearing session, FDA may Highlights of Prescribing Information 2017–D–6969 for ‘‘Product Title and
conduct a lottery to determine the (Highlights) contain a product title and Initial U.S. Approval in Highlights for
speakers for the scheduled open public the year of initial U.S. approval. This Human Prescription Drug and Biological
hearing session. The contact person will draft guidance provides Products—Content and Format;
notify interested persons regarding their recommendations on the content and Guidance for Industry; Availability.’’
request to speak by February 14, 2018. format of the product title and initial Received comments will be placed in
U.S. approval to bring greater the docket and, except for those
Persons attending FDA’s advisory
consistency to the presentation of these submitted as ‘‘Confidential
committee meetings are advised that required elements and to help ensure
FDA is not responsible for providing Submissions,’’ publicly viewable at
these elements provide clear and useful https://www.regulations.gov or at the
access to electrical outlets. information to the health care provider. Dockets Management Staff between 9
For press inquiries, please contact the DATES: Submit either electronic or a.m. and 4 p.m., Monday through
Office of Media Affairs at fdaoma@ written comments on the draft guidance Friday.
fda.hhs.gov or 301–796–4540. by March 20, 2018 to ensure that the • Confidential Submissions—To
FDA welcomes the attendance of the Agency considers your comment on this submit a comment with confidential
public at its advisory committee draft guidance before it begins work on information that you do not wish to be
meetings and will make every effort to the final version of the guidance. made publicly available, submit your
accommodate persons with disabilities. ADDRESSES: You may submit comments comments only as a written/paper
If you require accommodations due to a on any guidance at any time as follows: submission. You should submit two
disability, please contact Jay R. copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Fajiculay (See, FOR FURTHER
INFORMATION CONTACT) at least 7 days in Submit electronic comments in the with a heading or cover note that states
advance of the meeting. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
FDA is committed to the orderly
https://www.regulations.gov. Follow the Agency will review this copy, including
conduct of its advisory committee
instructions for submitting comments. the claimed confidential information, in
meetings. Please visit our website at
Comments submitted electronically, its consideration of comments. The
https://www.fda.gov/
including attachments, to https:// second copy, which will have the
AdvisoryCommittees/
www.regulations.gov will be posted to claimed confidential information
AboutAdvisoryCommittees/ the docket unchanged. Because your redacted/blacked out, will be available
ucm111462.htm for procedures on comment will be made public, you are for public viewing and posted on
public conduct during advisory solely responsible for ensuring that your https://www.regulations.gov. Submit
committee meetings. comment does not include any both copies to the Dockets Management
Notice of this meeting is given under confidential information that you or a Staff. If you do not wish your name and
the Federal Advisory Committee Act (5 third party may not wish to be posted, contact information to be made publicly
daltland on DSKBBV9HB2PROD with NOTICES
U.S.C. app. 2). such as medical information, your or available, you can provide this
Dated: January 10, 2018. anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Leslie Kux,
as a manufacturing process. Please note must identify this information as
Associate Commissioner for Policy. that if you include your name, contact ‘‘confidential.’’ Any information marked
[FR Doc. 2018–00903 Filed 1–18–18; 8:45 am] information, or other information that as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P identifies you in the body of your except in accordance with 21 CFR 10.20
VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/83_FR_2807/page/3.svg)
Document Created: 2018-01-19 02:42:53
Document Modified: 2018-01-19 02:42:53
| 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 March 8, 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 the 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 2794 |
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