83 FR 9324 - 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 43 (March 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 43 (March 5, 2018)
| Page Range | 9324-9325 | |
| FR Document | 2018-04400 |
[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)] [Notices] [Pages 9324-9325] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04400] ----------------------------------------------------------------------- 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) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between October 23, 2017, and March 16, 2018, on FDA's website but not presented at the March 23, 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 March 30, 2018. ADDRESSES: FDA is establishing a docket for public comment on this document. The docket number is FDA-2017-N-7022. The docket will close on March 30, 2018. Submit either electronic or written comments by that date. Please note that late, untimely comments will not be considered. Electronic comments must be submitted on or before March 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 30, 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 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 [[Page 9325]] 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 is establishing a public docket, Docket No. FDA-2017-N-7022, to receive input on post-marketing pediatric-focused safety reviews of products posted between October 23, 2017, and March 16, 2018, available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but not presented at the March 23, 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 on March 19, 2018, and remain open until March 30, 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. EPICEL (cultured epidermal autographs) (humanitarian device exemption (HDE)) 2. GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 3. TRUMENBA (Meningococcal Group B Vaccine) Center for Drug Evaluation and Research 1. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% 2. DYMISTA (azelastine hydrochloride/fluticasone propionate) 3. EDURANT (rilpivirine); COMPLERA (emtricitabine, rilpivirine, tenofovir disoproxil fumarate); ODEFSEY (emtricitabine, rilpivirine, tenofovir alafenamide) 4. EMEND (aprepitant) capsule and oral suspension 5. EPIDUO FORTE (adapalene/benzoyl peroxide, 0.3%/2.5%) gel 6. GADAVIST (gadobutrol); EOVIST (Primovist; gadoxetate disodium) 7. GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets 8. KAPVAY (clonidine extended-release) tablets 9. MERREM IV (meropenem for injection) 10. NAFTIN (naftifine hydrochloride) 11. NUCALA (mepolizumab) 12. OTIPRIO (6% ciprofloxacin otic suspension) 13. PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% 14. QNASL (beclomethasone dipropionate) nasal aerosol 15. SAPHRIS (asenapine) 16. TIVICAY (dolutegravir) 17. TREXIMET (naproxen sodium; sumatriptan succinate) 18. VALCYTE (valganciclovir) Center for Devices and Radiological Health 1. FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE) Dated: February 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04400 Filed 3-2-18; 8:45 am] BILLING CODE 4164-01-P
![9324 Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
Estimated Total Annual Burden not presented at the March 23, 2018, Management Staff (HFA–305), Food and
Hours: 2,925 hours. Pediatric Advisory Committee (PAC) Drug Administration, 5630 Fishers
In compliance with the requirements meeting. These reviews are intended to Lane, Rm. 1061, Rockville, MD 20852.
of the Paperwork Reduction Act of 1995 be available for review and comment by • For written/paper comments
(Pub. L. 104–13, 44 U.S.C. Chap 35), the members of the PAC, interested parties submitted to the Dockets Management
Administration for Children and (such as academic researchers, regulated Staff, FDA will post your comment, as
Families is soliciting public comment industries, consortia, and patient well as any attachments, except for
on the specific aspects of the groups), and the general public. information submitted, marked and
information collection described above. DATES: Submit either electronic or identified, as confidential, if submitted
Copies of the proposed collection of written comments by March 30, 2018. as detailed in ‘‘Instructions.’’
information can be obtained and ADDRESSES: FDA is establishing a docket
Instructions: All submissions received
comments may be forwarded by writing for public comment on this document. must include the Docket No. FDA–
to the Administration for Children and The docket number is FDA–2017–N– 2017–N–7022 for ‘‘Post-Marketing
Families, Office of Planning, Research 7022. The docket will close on March Pediatric-Focused Product Safety
and Evaluation, 330 C Street SW, 30, 2018. Submit either electronic or Reviews; Establishment of a Public
Washington DC 20201. Attn: ACF written comments by that date. Please Docket; Request for Comments.’’
Reports Clearance Officer. Email note that late, untimely comments will Received comments, those filed in a
address: infocollection@acf.hhs.gov. All not be considered. Electronic comments timely manner (see ADDRESSES), will be
requests should be identified by the title must be submitted on or before March placed in the docket and, except for
of the information collection. 30, 2018. The https:// those submitted as ‘‘Confidential
The Department specifically requests www.regulations.gov electronic filing Submissions,’’ publicly viewable at
comments on: (a) Whether the proposed system will accept comments until https://www.regulations.gov or at the
collection of information is necessary midnight Eastern Time at the end of Dockets Management Staff between 9
for the proper performance of the March 30, 2018. Comments received by a.m. and 4 p.m., Monday through
functions of the agency, including mail/hand delivery/courier (for written/ Friday.
• Confidential Submissions—To
whether the information shall have paper submissions) will be considered
submit a comment with confidential
practical utility; (b) the accuracy of the timely if they are postmarked or the
information that you do not wish to be
agency’s estimate of the burden of the delivery service acceptance receipt is on
made publicly available, submit your
proposed collection of information; (c) or before that date.
You may submit comments as comments only as a written/paper
the quality, utility, and clarity of the
follows: submission. You should submit two
information to be collected; and (d)
copies total. One copy will include the
ways to minimize the burden of the Electronic Submissions information you claim to be confidential
collection of information on
Submit electronic comments in the with a heading or cover note that states
respondents, including through the use
following way: ‘‘THIS DOCUMENT CONTAINS
of automated collection techniques or
other forms of information technology. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ FDA
https://www.regulations.gov. Follow the will review this copy, including the
Consideration will be given to claimed confidential information, in its
comments and suggestions submitted instructions for submitting comments.
Comments submitted electronically, consideration of comments. The second
within 60 days of this publication. copy, which will have the claimed
including attachments, to https://
Robert Sargis, www.regulations.gov will be posted to confidential information redacted/
Reports Clearance Officer. the docket unchanged. Because your blacked out, will be available for public
[FR Doc. 2018–04384 Filed 3–2–18; 8:45 am] comment will be made public, you are viewing and posted on https://
BILLING CODE 4184–01–P solely responsible for ensuring that your www.regulations.gov. Submit both
comment does not include any copies to the Dockets Management Staff.
confidential information that you or a If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted, contact information to be made publicly
HUMAN SERVICES such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
[Docket No. FDA–2017–N–7022]
that if you include your name, contact ‘‘confidential.’’ Any information marked
Post-Marketing Pediatric-Focused information, or other information that as ‘‘confidential’’ will not be disclosed
Product Safety Reviews; identifies you in the body of your except in accordance with 21 CFR 10.20
Establishment of a Public Docket; comments, that information will be and other applicable disclosure law. For
Request for Comments posted on https://www.regulations.gov. more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
AGENCY: Food and Drug Administration, with confidential information that you FR 56469, September 18, 2015, or access
HHS. do not wish to make available to the the information at: https://www.gpo.gov/
ACTION: Notice, establishment of a public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
public docket; request for comments. written/paper submission and in the 23389.pdf.
Docket: For access to the docket to
sradovich on DSK3GMQ082PROD with NOTICES
manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). read background documents or the
Administration (FDA) is establishing a electronic and written/paper comments
public docket to collect comments Written/Paper Submissions received, go to https://
related to the post-marketing pediatric- Submit written/paper submissions as www.regulations.gov and insert the
focused safety reviews of products follows: docket number, found in brackets in the
posted between October 23, 2017, and • Mail/Hand delivery/Courier (for heading of this document, into the
March 16, 2018, on FDA’s website but written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
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![Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices 9325
and/or go to the Dockets Management fumarate); ODEFSEY (emtricitabine, the document identifier 0990–New–60D
Staff, 5630 Fishers Lane, Rm. 1061, rilpivirine, tenofovir alafenamide) and project title for reference to
Rockville, MD 20852. 4. EMEND (aprepitant) capsule and Sherrette.funn@hhs.gov or call the
FOR FURTHER INFORMATION CONTACT: oral suspension Reports Clearance Officer.
Kenneth Quinto, Office of the 5. EPIDUO FORTE (adapalene/ SUPPLEMENTARY INFORMATION: Interested
Commissioner, Food and Drug benzoyl peroxide, 0.3%/2.5%) gel persons are invited to send comments
Administration, 10903 New Hampshire 6. GADAVIST (gadobutrol); EOVIST regarding this burden estimate or any
Ave., Bldg. 32, Rm. 5145, Silver Spring, (Primovist; gadoxetate disodium) other aspect of this collection of
MD 20993, 240–402–2221, 7. GENVOYA (elvitegravir, cobicistat, information, including any of the
kenneth.quinto@fda.hhs.gov. emtricitabine, and tenofovir following subjects: (1) The necessity and
alafenamide) oral tablets utility of the proposed information
SUPPLEMENTARY INFORMATION: FDA is
8. KAPVAY (clonidine extended- collection for the proper performance of
responsible for protecting the public release) tablets
health by assuring the safety, efficacy, the agency’s functions; (2) the accuracy
9. MERREM IV (meropenem for of the estimated burden; (3) ways to
and security of human and veterinary injection)
drugs, biological products, medical enhance the quality, utility, and clarity
10. NAFTIN (naftifine hydrochloride) of the information to be collected; and
devices, our Nation’s food supply, 11. NUCALA (mepolizumab)
cosmetics, and products that emit (4) the use of automated collection
12. OTIPRIO (6% ciprofloxacin otic techniques or other forms of information
radiation. suspension)
FDA is establishing a public docket, technology to minimize the information
13. PAZEO (olopatadine collection burden.
Docket No. FDA–2017–N–7022, to hydrochloride ophthalmic solution) Title of the Collection: Trafficking
receive input on post-marketing 0.7% Victim Assistance Program Social
pediatric-focused safety reviews of 14. QNASL (beclomethasone Network Analysis—Network Survey.
products posted between October 23, dipropionate) nasal aerosol Type of Collection: New.
2017, and March 16, 2018, available on 15. SAPHRIS (asenapine) OMB No. 0990–NEW-Office of the
FDA’s website at https://www.fda.gov/ 16. TIVICAY (dolutegravir) Assistant Secretary for Planning and
AdvisoryCommittees/Committees 17. TREXIMET (naproxen sodium; Evaluation–Administration for Children
MeetingMaterials/PediatricAdvisory sumatriptan succinate) and Families’ Trafficking Victim
Committee/ucm510701.htm but not 18. VALCYTE (valganciclovir) Assistance Program
presented at the March 23, 2018, PAC
meeting. FDA welcomes comments by Center for Devices and Radiological Abstract
members of the PAC, as mandated by Health The Office of the Assistant Secretary
the Best Pharmaceuticals for Children 1. FLOURISH PEDIATRIC for Planning and Evaluation (ASPE), in
Act (Pub. L. 107–109) and the Pediatric ESOPHAGEAL ATRESIA DEVICE partnership with the Administration for
Research Equity Act of 2003 (Pub. L. (HDE) Children and Families (ACF), U.S.
108–155), interested parties (such as Dated: February 28, 2018. Department of Health and Human
academic researchers, regulated Leslie Kux,
Services (HHS) is requesting Office of
industries, consortia, and patient Management and Budget (OMB)
Associate Commissioner for Policy.
groups), and the general public. The approval for a new information
[FR Doc. 2018–04400 Filed 3–2–18; 8:45 am] collection request, ‘‘Trafficking Victim
docket number is FDA–2017–N–7022.
The docket will open on March 19, BILLING CODE 4164–01–P Assistance Program (TVAP) Network
2018, and remain open until March 30, Survey.’’ ICF has been contracted to
2018. The post-marketing pediatric- carry out this project under the
focused safety reviews are for the DEPARTMENT OF HEALTH AND guidance of ASPE and ACF.
following products from the following HUMAN SERVICES TVAP, as authorized by the
centers at FDA: [Document Identifier OS–0990–New] Trafficking Victims Protection Act of
2000, provides comprehensive case
Center for Biologics Evaluation and Agency Information Collection management services to foreign-born
Research Request; 60-Day Public Comment victims of human trafficking residing in
1. EPICEL (cultured epidermal Request the United States. Since its inception,
autographs) (humanitarian device TVAP funding and infrastructure have
AGENCY: Office of the Secretary, HHS. remained relatively unchanged: Services
exemption (HDE))
2. GARDASIL 9 (Human ACTION: Notice. are paid on a per capita basis, and funds
Papillomavirus 9-valent Vaccine, are managed through three primary
SUMMARY: In compliance with the
Recombinant) grantees that enter into cooperative
requirement of the Paperwork
3. TRUMENBA (Meningococcal agreements with service providers
Reduction Act of 1995, the Office of the
Group B Vaccine) (subrecipients). Given the changing
Secretary (OS), Department of Health
landscape and the greater understanding
Center for Drug Evaluation and and Human Services, is publishing the
of the nature and extent of trafficking,
Research following summary of a proposed
HHS is undertaking a program
collection for public comment.
1. ATROPINE SULFATE assessment to understand whether any
OPHTHALMIC SOLUTION, USP DATES: Comments on the ICR must be efficiencies can be gained in the
sradovich on DSK3GMQ082PROD with NOTICES
1% received on or before May 4, 2018. program administration and structure.
2. DYMISTA (azelastine ADDRESSES: Submit your comments to Building on an earlier fiscal year 2018
hydrochloride/fluticasone Sherrette.Funn@hhs.gov or by calling assessment to solicit qualitative
propionate) 202–795–7714. feedback from a range of program
3. EDURANT (rilpivirine); FOR FURTHER INFORMATION CONTACT: stakeholders, the information collected
COMPLERA (emtricitabine, When submitting comments or for this program survey aims to help
rilpivirine, tenofovir disoproxil requesting information, please include HHS determine if efficiencies can be
VerDate Sep<11>2014 19:25 Mar 02, 2018 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/83_FR_9367/page/2.svg)
Document Created: 2018-03-03 02:46:00
Document Modified: 2018-03-03 02:46:00
| 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 | Submit either electronic or written comments by March 30, 2018. | |
| 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] | |
| FR Citation | 83 FR 9324 |
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