Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments, 47177-47178 [2018-20214]

Download as PDF Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices 47177 ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours Second follow-up survey ...................................................... 4,800 1,600 1 1 1,600 Estimated Total Annual Burden Hours: 1,600. DEPARTMENT OF HEALTH AND HUMAN SERVICES Comments due within 60 days of publication. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Food and Drug Administration DATES: Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. ADDRESSES: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES Authority: Section 413 of the Social Security Act, as amended by the FY 2017 Consolidated Appropriations Act, 2017 (Pub. L. 115–31). Emily B. Jabbour, ACF/OPRE Certifying Officer. [FR Doc. 2018–20223 Filed 9–17–18; 8:45 am] BILLING CODE 4184–09–P VerDate Sep<11>2014 19:14 Sep 17, 2018 Jkt 244001 [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. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) has established a public docket to collect comments related to the post-marketing, pediatricfocused 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. SUMMARY: Submit either electronic or written comments by September 28, 2018. DATES: 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: ADDRESSES: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 E:\FR\FM\18SEN1.SGM 18SEN1 daltland on DSKBBV9HB2PROD with NOTICES 47178 Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, kenneth.quinto@fda.hhs.gov. 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. VerDate Sep<11>2014 19:14 Sep 17, 2018 Jkt 244001 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 pediatricfocused safety reviews are for the following products from the following centers at FDA: 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 Biologics Evaluation and Research 1. BEXSERO (Meningococcal Group B Vaccine) 2. QUADRACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Dated: September 12, 2018. Leslie Kux, Associate Commissioner for Policy. 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) PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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) [FR Doc. 2018–20214 Filed 9–17–18; 8:45 a.m.] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3159] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic 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 a docket for public comment on this document. DATES: The meeting will be held on October 24 and 25, 2018, from 8 a.m. to 5 p.m. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 SUMMARY: E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47177-47178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20214]


-----------------------------------------------------------------------

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.gpo.gov/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
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