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.

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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 VerDate Sep<11>2014 19:14 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1


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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