83_FR_47358 83 FR 47177 - Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments

83 FR 47177 - Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 181 (September 18, 2018)

Page Range47177-47178
FR Document2018-20214

The Food and Drug Administration (FDA) has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between April 2, 2018, and September 14, 2018, on FDA's website but not presented at the September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

Federal Register, Volume 83 Issue 181 (Tuesday, September 18, 2018)
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47177-47178]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-7022]


Post-Marketing Pediatric-Focused Product Safety Reviews; 
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) has established a 
public docket to collect comments related to the post-marketing, 
pediatric-focused safety reviews of products posted between April 2, 
2018, and September 14, 2018, on FDA's website but not presented at the 
September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These 
reviews are intended to be available for review and comment by members 
of the PAC, interested parties (such as academic researchers, regulated 
industries, consortia, and patient groups), and the general public.

DATES: Submit either electronic or written comments by September 28, 
2018.

ADDRESSES: FDA has established a docket for public comment on this 
document. The docket number is FDA-2017-N-7022. The docket will close 
on September 28, 2018. Submit either electronic or written comments by 
that date. Please note that late, untimely filed comments will not be 
considered. Electronic comments must be submitted on or before 
September 28, 2018. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
September 28, 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.
    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 make 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-2017-N-7022 for ``Post-Marketing Pediatric-Focused Product Safety 
Reviews; 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

[[Page 47178]]

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 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: Kenneth Quinto, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5145, Silver Spring, MD 20993, 240-402-2221, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public 
health by assuring the safety, efficacy, and security of human and 
veterinary drugs, biological products, medical devices, our Nation's 
food supply, cosmetics, and products that emit radiation. FDA also has 
responsibility for regulating the manufacturing, marketing, and 
distribution of tobacco products to protect the public health and to 
reduce tobacco use by minors.
    FDA has established a public docket, Docket No. FDA-2017-N-7022, to 
receive input on post-marketing pediatric-focused safety reviews of 
products posted between April 2, 2018, and September 14, 2018, 
available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but 
not presented at the September 20, 2018, PAC meeting. FDA welcomes 
comments by members of the PAC, as mandated by the Best Pharmaceuticals 
for Children Act (Pub. L. 107-109) and the Pediatric Research Equity 
Act of 2003 (Pub. L. 108-155), interested parties (such as academic 
researchers, regulated industries, consortia, and patient groups), and 
the general public. The docket number is FDA-2017-N-7022. The docket 
will open for comments on September 17, 2018, and remain open until 
September 28, 2018. The post-marketing pediatric-focused safety reviews 
are for the following products from the following centers at FDA:

Center for Biologics Evaluation and Research

1. BEXSERO (Meningococcal Group B Vaccine)
2. QUADRACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis 
Adsorbed and Inactivated Poliovirus Vaccine)

Center for Drug Evaluation and Research

1. ADZENYS XR-ODT (amphetamine tablet) and DYANAVEL XR (amphetamine 
suspension)
2. ANTHIM (obiltoxaximab)
3. APTENSIO XR (methylphenidate hydrochloride) and QUILLICHEW ER 
(methylphenidate hydrochloride)
4. BANZEL (rufinamide)
5. CINQAIR (reslizumab)
6. CUTIVATE (fluticasone propionate)
7. DESCOVY (emtricitabine and tenofovir alafenamide)
8. ENTOCORT EC (budesonide)
9. EPIVIR (lamivudine)
10. EPZICOM (abacavir sulfate and lamivudine) and ZIAGEN (abacavir 
sulfate)
11. KALETRA (lopinavir and ritonavir)
12. KOVANAZE (tetracaine hydrochloride and oxymetazoline hydrochloride)
13. LAMICTAL (lamotrigine)
14. NATROBA (spinosad)
15. NOXAFIL (posaconazole)
16. ORALTAG (iohexol)
17. ORAVERSE (phentolamine mesylate)
18. OTOVEL (ciprofloxacin and fluocinolone acetonide)
19. PANCREAZE (pancrelipase) and PERTZYE (pancrelipase)
20. PRILOSEC (omeprazole)
21. PROAIR RESPICLICK (abuterol sulfate)
22. PROCYSBI (cysteamine bitartrate)
23. RENVELA (sevelamer carbonate)
24. SPIRIVA (tiotropium bromide)
25. TEFLARO (ceftaroline fosamil)
26. TETRACAINE HYDROCHLORIDE Ophthalmic Solution (tetracaine 
hydrochloride)
27. XOPENEX (levalbuterol)
28. ZOMIG Nasal Spray (zolmitriptan)

Center for Devices and Radiological Health

1. CONTEGRA PULMONARY VALVED CONDUIT (Humanitarian Device Exemption 
(HDE))
2. ELANA SURGICAL KIT (HDE)
3. ENTERRA THERAPY SYSTEM (HDE)
4. LIPOSORBER LA-15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
6. PLEXIMMUNE (HDE)
7. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20214 Filed 9-17-18; 8:45 a.m.]
BILLING CODE 4164-01-P



                                                                              Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices                                                      47177

                                                                                                                        ANNUAL BURDEN ESTIMATES
                                                                                                                                                       Annual            Number of           Average
                                                                                                                                  Total number                                                            Annual burden
                                                                              Instrument                                                             number of         responses per       burden hours
                                                                                                                                 of respondents                                                              hours
                                                                                                                                                    respondents          respondent        per response

                                               Second follow-up survey ......................................................        4,800                 1,600             1                  1             1,600



                                                Estimated Total Annual Burden                                   DEPARTMENT OF HEALTH AND                                 Electronic Submissions
                                               Hours: 1,600.                                                    HUMAN SERVICES                                             Submit electronic comments in the
                                               DATES: Comments due within 60 days of                                                                                     following way:
                                                                                                                Food and Drug Administration                               • Federal eRulemaking Portal:
                                               publication. In compliance with the
                                               requirements of Section 3506(c)(2)(A) of                                                                                  https://www.regulations.gov. Follow the
                                                                                                                [Docket No. FDA–2017–N–7022]                             instructions for submitting comments.
                                               the Paperwork Reduction Act of 1995,
                                                                                                                                                                         Comments submitted electronically,
                                               the Administration for Children and                              Post-Marketing Pediatric-Focused                         including attachments, to https://
                                               Families is soliciting public comment                            Product Safety Reviews;                                  www.regulations.gov will be posted to
                                               on the specific aspects of the                                   Establishment of a Public Docket;                        the docket unchanged. Because your
                                               information collection described above.                          Request for Comments                                     comment will be made public, you are
                                               ADDRESSES:   Copies of the proposed                                                                                       solely responsible for ensuring that your
                                                                                                                AGENCY:         Food and Drug Administration,            comment does not include any
                                               collection of information can be                                 HHS.
                                               obtained and comments may be                                                                                              confidential information that you or a
                                               forwarded by writing to the                                      ACTION: Notice; establishment of a                       third party may not wish to be posted,
                                               Administration for Children and                                  public docket; request for comments.                     such as medical information, your or
                                                                                                                                                                         anyone else’s Social Security number, or
                                               Families, Office of Planning, Research,
                                                                                                                SUMMARY:   The Food and Drug                             confidential business information, such
                                               and Evaluation, 330 C Street SW,
                                                                                                                Administration (FDA) has established a                   as a manufacturing process. Please note
                                               Washington, DC 20201, Attn: OPRE
                                                                                                                public docket to collect comments                        that if you include your name, contact
                                               Reports Clearance Officer. Email                                                                                          information, or other information that
                                                                                                                related to the post-marketing, pediatric-
                                               address: OPREinfocollection@                                                                                              identifies you in the body of your
                                                                                                                focused safety reviews of products
                                               acf.hhs.gov. All requests should be                                                                                       comments, that information will be
                                                                                                                posted between April 2, 2018, and
                                               identified by the title of the information                       September 14, 2018, on FDA’s website                     posted on https://www.regulations.gov.
                                               collection.                                                      but not presented at the September 20,                     • If you want to submit a comment
                                               SUPPLEMENTARY INFORMATION:       The                             2018, Pediatric Advisory Committee                       with confidential information that you
                                               Department specifically requests                                 (PAC) meeting. These reviews are                         do not wish to make available to the
                                               comments on (a) whether the proposed                             intended to be available for review and                  public, submit the comment as a
                                                                                                                comment by members of the PAC,                           written/paper submission and in the
                                               collection of information is necessary
                                                                                                                interested parties (such as academic                     manner detailed (see ‘‘Written/Paper
                                               for the proper performance of the
                                                                                                                researchers, regulated industries,                       Submissions’’ and ‘‘Instructions’’).
                                               functions of the agency, including
                                               whether the information shall have                               consortia, and patient groups), and the                  Written/Paper Submissions
                                               practical utility; (b) the accuracy of the                       general public.
                                                                                                                                                                           Submit written/paper submissions as
                                               agency’s estimate of the burden of the                           DATES: Submit either electronic or                       follows:
                                               proposed collection of information; (c)                          written comments by September 28,                          • Mail/Hand Delivery/Courier (for
                                               the quality, utility, and clarity of the                         2018.                                                    written/paper submissions): Dockets
                                               information to be collected; and (d)                                                                                      Management Staff (HFA–305), Food and
                                                                                                                ADDRESSES:   FDA has established a                       Drug Administration, 5630 Fishers
                                               ways to minimize the burden of the
                                                                                                                docket for public comment on this                        Lane, Rm. 1061, Rockville, MD 20852.
                                               collection of information on                                     document. The docket number is FDA–
                                               respondents, including through the use                                                                                      • For written/paper comments
                                                                                                                2017–N–7022. The docket will close on                    submitted to the Dockets Management
                                               of automated collection techniques or                            September 28, 2018. Submit either
                                               other forms of information technology.                                                                                    Staff, FDA will post your comment, as
                                                                                                                electronic or written comments by that                   well as any attachments, except for
                                               Consideration will be given to                                   date. Please note that late, untimely
                                               comments and suggestions submitted                                                                                        information submitted, marked and
                                                                                                                filed comments will not be considered.                   identified, as confidential, if submitted
                                               within 60 days of this publication.                              Electronic comments must be submitted                    as detailed in ‘‘Instructions.’’
                                                 Authority: Section 413 of the Social                           on or before September 28, 2018. The                       Instructions: All submissions received
                                               Security Act, as amended by the FY 2017                          https://www.regulations.gov electronic                   must include the Docket No. FDA–
                                               Consolidated Appropriations Act, 2017 (Pub.                      filing system will accept comments                       2017–N–7022 for ‘‘Post-Marketing
                                               L. 115–31).                                                      until midnight Eastern Time at the end                   Pediatric-Focused Product Safety
                                                                                                                of September 28, 2018. Comments                          Reviews; Establishment of a Public
                                               Emily B. Jabbour,                                                received by mail/hand delivery/courier                   Docket; Request for Comments.’’
daltland on DSKBBV9HB2PROD with NOTICES




                                               ACF/OPRE Certifying Officer.                                     (for written/paper submissions) will be                  Received comments, those filed in a
                                               [FR Doc. 2018–20223 Filed 9–17–18; 8:45 am]                      considered timely if they are                            timely manner (see ADDRESSES), will be
                                               BILLING CODE 4184–09–P                                           postmarked or the delivery service                       placed in the docket and, except for
                                                                                                                acceptance receipt is on or before that                  those submitted as ‘‘Confidential
                                                                                                                date.                                                    Submissions,’’ publicly viewable at
                                                                                                                   You may submit comments as                            https://www.regulations.gov or at the
                                                                                                                follows:                                                 Dockets Management Staff between 9


                                          VerDate Sep<11>2014      19:14 Sep 17, 2018     Jkt 244001     PO 00000     Frm 00054     Fmt 4703   Sfmt 4703    E:\FR\FM\18SEN1.SGM   18SEN1


                                               47178                     Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices

                                               a.m. and 4 p.m., Monday through                           FDA has established a public docket,                19. PANCREAZE (pancrelipase) and
                                               Friday.                                                 Docket No. FDA–2017–N–7022, to                             PERTZYE (pancrelipase)
                                                  • Confidential Submissions—To                        receive input on post-marketing                       20. PRILOSEC (omeprazole)
                                               submit a comment with confidential                      pediatric-focused safety reviews of                   21. PROAIR RESPICLICK (abuterol
                                               information that you do not wish to be                  products posted between April 2, 2018,                     sulfate)
                                               made publicly available, submit your                    and September 14, 2018, available on                  22. PROCYSBI (cysteamine bitartrate)
                                               comments only as a written/paper                        FDA’s website at https://www.fda.gov/                 23. RENVELA (sevelamer carbonate)
                                               submission. You should submit two                       AdvisoryCommittees/                                   24. SPIRIVA (tiotropium bromide)
                                               copies total. One copy will include the                 CommitteesMeetingMaterials/                           25. TEFLARO (ceftaroline fosamil)
                                               information you claim to be confidential                PediatricAdvisoryCommittee/                           26. TETRACAINE HYDROCHLORIDE
                                               with a heading or cover note that states                ucm510701.htm but not presented at the                     Ophthalmic Solution (tetracaine
                                               ‘‘THIS DOCUMENT CONTAINS                                September 20, 2018, PAC meeting. FDA                       hydrochloride)
                                               CONFIDENTIAL INFORMATION.’’ FDA                         welcomes comments by members of the                   27. XOPENEX (levalbuterol)
                                               will review this copy, including the                    PAC, as mandated by the Best                          28. ZOMIG Nasal Spray (zolmitriptan)
                                               claimed confidential information, in its                Pharmaceuticals for Children Act (Pub.                Center for Devices and Radiological
                                               consideration of comments. The second                   L. 107–109) and the Pediatric Research                Health
                                               copy, which will have the claimed                       Equity Act of 2003 (Pub. L. 108–155),
                                               confidential information redacted/                      interested parties (such as academic                  1. CONTEGRA PULMONARY VALVED
                                               blacked out, will be available for public               researchers, regulated industries,                         CONDUIT (Humanitarian Device
                                               viewing and posted on https://                          consortia, and patient groups), and the                    Exemption (HDE))
                                               www.regulations.gov. Submit both                        general public. The docket number is                  2. ELANA SURGICAL KIT (HDE)
                                               copies to the Dockets Management Staff.                 FDA–2017–N–7022. The docket will                      3. ENTERRA THERAPY SYSTEM (HDE)
                                               If you do not wish your name and                        open for comments on September 17,                    4. LIPOSORBER LA–15 SYSTEM (HDE)
                                               contact information to be made publicly                 2018, and remain open until September                 5. MEDTRONIC ACTIVA DYSTONIA
                                               available, you can provide this                         28, 2018. The post-marketing pediatric-                    THERAPY (HDE)
                                               information on the cover sheet and not                  focused safety reviews are for the                    6. PLEXIMMUNE (HDE)
                                               in the body of your comments and you                    following products from the following                 7. PULSERIDER ANEURYSM NECK
                                               must identify this information as                       centers at FDA:                                            RECONSTRUCTION DEVICE (HDE)
                                               ‘‘confidential.’’ Any information marked                                                                        Dated: September 12, 2018.
                                                                                                       Center for Biologics Evaluation and
                                               as ‘‘confidential’’ will not be disclosed                                                                     Leslie Kux,
                                                                                                       Research
                                               except in accordance with 21 CFR 10.20                                                                        Associate Commissioner for Policy.
                                               and other applicable disclosure law. For                1. BEXSERO (Meningococcal Group B
                                                                                                                                                             [FR Doc. 2018–20214 Filed 9–17–18; 8:45 a.m.]
                                               more information about FDA’s posting                        Vaccine)
                                                                                                       2. QUADRACEL (Diphtheria and                          BILLING CODE 4164–01–P
                                               of comments to public dockets, see 80
                                               FR 56469, September 18, 2015, or access                     Tetanus Toxoids and Acellular
                                               the information at: https://www.gpo.gov/                    Pertussis Adsorbed and Inactivated
                                                                                                                                                             DEPARTMENT OF HEALTH AND
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                           Poliovirus Vaccine)
                                                                                                                                                             HUMAN SERVICES
                                               23389.pdf.                                              Center for Drug Evaluation and
                                                  Docket: For access to the docket to                  Research                                              Food and Drug Administration
                                               read background documents or the
                                               electronic and written/paper comments                   1. ADZENYS XR–ODT (amphetamine                        [Docket No. FDA–2018–N–3159]
                                               received, go to https://                                     tablet) and DYANAVEL XR
                                                                                                            (amphetamine suspension)                         Endocrinologic and Metabolic Drugs
                                               www.regulations.gov and insert the                                                                            Advisory Committee; Notice of
                                               docket number, found in brackets in the                 2. ANTHIM (obiltoxaximab)
                                                                                                       3. APTENSIO XR (methylphenidate                       Meeting; Establishment of a Public
                                               heading of this document, into the                                                                            Docket; Request for Comments
                                                                                                            hydrochloride) and QUILLICHEW
                                               ‘‘Search’’ box and follow the prompts
                                                                                                            ER (methylphenidate
                                               and/or go to the Dockets Management                                                                           AGENCY:    Food and Drug Administration,
                                                                                                            hydrochloride)
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     4. BANZEL (rufinamide)                                HHS.
                                               Rockville, MD 20852.                                    5. CINQAIR (reslizumab)                               ACTION: Notice; establishment of a
                                               FOR FURTHER INFORMATION CONTACT:                        6. CUTIVATE (fluticasone propionate)                  public docket; request for comments.
                                               Kenneth Quinto, Office of the                           7. DESCOVY (emtricitabine and
                                               Commissioner, Food and Drug                                  tenofovir alafenamide)                           SUMMARY:   The Food and Drug
                                               Administration, 10903 New Hampshire                     8. ENTOCORT EC (budesonide)                           Administration (FDA) announces a
                                               Ave., Bldg. 32, Rm. 5145, Silver Spring,                9. EPIVIR (lamivudine)                                forthcoming public advisory committee
                                               MD 20993, 240–402–2221,                                 10. EPZICOM (abacavir sulfate and                     meeting of the Endocrinologic and
                                               kenneth.quinto@fda.hhs.gov.                                  lamivudine) and ZIAGEN (abacavir                 Metabolic Drugs Advisory Committee.
                                               SUPPLEMENTARY INFORMATION: FDA is                            sulfate)                                         The general function of the committee is
                                               responsible for protecting the public                   11. KALETRA (lopinavir and ritonavir)                 to provide advice and recommendations
                                                                                                       12. KOVANAZE (tetracaine                              to FDA on regulatory issues. The
                                               health by assuring the safety, efficacy,
                                                                                                            hydrochloride and oxymetazoline                  meeting will be open to the public. FDA
                                               and security of human and veterinary
                                                                                                            hydrochloride)                                   is establishing a docket for public
                                               drugs, biological products, medical                     13. LAMICTAL (lamotrigine)
daltland on DSKBBV9HB2PROD with NOTICES




                                               devices, our Nation’s food supply,                                                                            comment on this document.
                                                                                                       14. NATROBA (spinosad)
                                               cosmetics, and products that emit                                                                             DATES: The meeting will be held on
                                                                                                       15. NOXAFIL (posaconazole)
                                               radiation. FDA also has responsibility                  16. ORALTAG (iohexol)                                 October 24 and 25, 2018, from 8 a.m. to
                                               for regulating the manufacturing,                       17. ORAVERSE (phentolamine                            5 p.m.
                                               marketing, and distribution of tobacco                       mesylate)                                        ADDRESSES: The meeting will be held at
                                               products to protect the public health                   18. OTOVEL (ciprofloxacin and                         the FDA White Oak Campus, 10903
                                               and to reduce tobacco use by minors.                         fluocinolone acetonide)                          New Hampshire Ave., Bldg. 31


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Document Created: 2018-09-18 01:18:06
Document Modified: 2018-09-18 01:18:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket; request for comments.
DatesSubmit either electronic or written comments by September 28, 2018.
ContactKenneth Quinto, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5145, Silver Spring, MD 20993, 240-402-2221, [email protected]
FR Citation83 FR 47177 

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