82_FR_42139 82 FR 41969 - Pediatric Post-Marketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments

82 FR 41969 - Pediatric Post-Marketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 170 (September 5, 2017)

Page Range41969-41970
FR Document2017-18690

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the pediatric post- marketing pharmacovigilance and drug utilization reviews of products posted between March 11, 2017, and September 12, 2017, on FDA's Web site but not presented at the September 12, 2017, 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 82 Issue 170 (Tuesday, September 5, 2017) 
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41969-41970]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4866]


Pediatric Post-Marketing Pharmacovigilance and Drug Utilization 
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) is establishing a 
public docket to collect comments related to the pediatric post-
marketing pharmacovigilance and drug utilization reviews of products 
posted between March 11, 2017, and September 12, 2017, on FDA's Web 
site but not presented at the September 12, 2017, 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 October 20, 
2017.

ADDRESSES: You may submit your comments as follows. Please note that 
late, untimely filed comments will not be considered. Electronic 
comments must be submitted on or before October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 20, 2017. 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.

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, you or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submission 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.

[[Page 41970]]

     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-4866 for the ``Pediatric Post-Marketing Pharmacovigilance 
and Drug Utilization Reviews'' that have been posted on FDA's Web site 
between March 11, 2017, and September 12, 2017, but not presented at 
the September 12, 2017, PAC meeting. 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 office 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.'' The Agency 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: 
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-4866, to 
receive input on pediatric post-marketing pharmacovigilance and drug 
utilization reviews posted between March 11, 2017, and September 12, 
2017, available on FDA's Web site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm, but not presented at the 
September 12, 2017, 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 (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-4866. The docket will open on October 9, 2017, and 
remain open until October 20, 2017. These pediatric post-marketing 
pharmacovigilance and drug utilization reviews are for the following 
products from the following centers at FDA:

Center for Biologics Evaluation and Research

1. GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for 
Sublingual Use
2. ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky 
Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use

Center for Drug Evaluation and Research

1. ALOXI (palonosetron hydrochloride)
2. ARNUITY ELLIPTA (fluticasone furoate)
3. ASMANEX HFA and ASMANEX TWISTHALER (mometasone furoate inhalation)
4. CYMBALTA (duloxetine)
5. EMSAM (selegiline transdermal system)
6. LATISSE (bimatoprost ophthalmic solution) 0.03%
7. NAMENDA (memantine hydrochloride) and NAMENDA XR (memantine 
hydrochloride) extended-release
8. PRIFTIN (rifapentine)
9. REYATAZ (atazanavir)
10. TACLONEX (betamethasone dipropionate/calcipotriene hydrate) Topical 
Suspension 0.064%/0.005% and TACLONEX (betamethasone dipropionate/
calcipotriene hydrate) Topical Ointment 0.064%/0.005%
11. ZETONNA (ciclesonide)

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18690 Filed 9-1-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41969 6366, 10903 New Hampshire Ave., Development of this guidance was 2017, on FDA’s Web site but not Silver Spring, MD 20993–0002, 240– facilitated by completion of the presented at the September 12, 2017, 402–0493; or Stephen Ripley, Center for ‘‘Pharmacy Systems Under REMS Pediatric Advisory Committee (PAC) Biologics Evaluation and Research, Project: Standardizing REMS meeting. These reviews are intended to Food and Drug Administration, 10903 Information for Inclusion Into Pharmacy be available for review and comment by New Hampshire Ave., Bldg. 71, Rm. Systems Using Structured Product members of the PAC, interested parties 7301, Silver Spring, MD 20993–0002, Labeling (SPL).’’ More information on (such as academic researchers, regulated 240–402–7911. this project—one of four predefined industries, consortia, and patient SUPPLEMENTARY INFORMATION: priority projects that are a part of the groups), and the general public. larger REMS Integration Initiative—can DATES: Submit either electronic or I. Background be found in the report ‘‘Standardizing written comments by October 20, 2017. FDA is announcing the availability of and Evaluating Risk Evaluation and ADDRESSES: You may submit your a draft guidance for industry entitled Mitigation Strategies (REMS)’’ (available comments as follows. Please note that ‘‘Providing Regulatory Submissions in at http://www.fda.gov/downloads/ late, untimely filed comments will not Electronic Format—Content of the Risk ForIndustry/UserFees/Prescription be considered. Electronic comments Evaluation and Mitigation Strategies DrugUserFee/UCM415751.pdf). must be submitted on or before October Document Using Structured Product II. Paperwork Reduction Act of 1995 20, 2017. The https:// Labeling; Draft Guidance for Industry.’’ www.regulations.gov electronic filing This notice refers to previously FDASIA (Pub. L. 112–144), amended system will accept comments until approved collections of information the FD&C Act to add section 745A (21 midnight Eastern Time at the end of found in FDA regulations. These U.S.C. 379k–1), entitled ‘‘Electronic October 20, 2017. Comments received collections of information are subject to Format for Submissions.’’ Section by mail/hand delivery/courier (for review by the Office of Management and 745A(a)(1) of the FD&C Act requires that written/paper submissions) will be Budget (OMB) under the Paperwork submissions under section 505(b), (i), or considered timely if they are Reduction Act of 1995 (44 U.S.C. 3501– (j) of the FD&C Act (21 U.S.C. 355(b), (i), postmarked or the delivery service 3520). The collections of information in or (j)) and submissions under section acceptance receipt is on or before that 21 CFR part 314 have been approved 351(a) or (k) of the PHS Act (42 U.S.C. date. under OMB control number 0910–0001. 262(a) or (k)) be submitted to FDA in electronic format no earlier than 24 III. Electronic Access Electronic Submissions months after FDA issues final guidance Persons with access to the Internet Submit electronic comments in the on electronic format for submissions. In may obtain the guidance at http:// following way: accordance with section 745A(a)(1) of www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: the FD&C Act, FDA is issuing this draft ComplianceRegulatoryInformation/ https://www.regulations.gov. Follow the guidance, announcing its determination Guidances/default.htm, http:// instructions for submitting comments. that submission types identified in the www.fda.gov/BiologicsBloodVaccines/ Comments submitted electronically, guidance must be submitted GuidanceComplianceRegulatory including attachments, to https:// electronically in the format specified in Information/Guidances/default.htm, or www.regulations.gov will be posted to the guidance beginning 24 months after http://www.regulations.gov. the docket unchanged. Because your the issuance of the final guidance. comment will be made public, you are Dated: August 23, 2017. This draft guidance (and the technical solely responsible for ensuring that your specification documents it references) Leslie Kux, comment does not include any describes how certain REMS documents Associate Commissioner for Policy. confidential information that you or a will be required to be submitted in [FR Doc. 2017–18506 Filed 9–1–17; 8:45 am] third party may not wish to be posted, electronic format using Structured BILLING CODE 4164–01–P such as medical information, you or Product Labeling (SPL) as outlined in anyone else’s Social Security number, or the FDA ‘‘Structured Product Labeling confidential business information, such (SPL) Implementation Guide with DEPARTMENT OF HEALTH AND as a manufacturing process. Please note Validation Procedures’’ (available at HUMAN SERVICES that if you include your name, contact http://www.fda.gov/downloads/ information, or other information that Food and Drug Administration ForIndustry/DataStandards/ identifies you in the body of your StructuredProductLabeling/ [Docket No. FDA–2017–N–4866] comments, that information will be UCM321876.pdf). (FDA has verified the posted on https://www.regulations.gov. Web site addresses, as of the date this Pediatric Post-Marketing • If you want to submit a comment document publishes in the Federal Pharmacovigilance and Drug with confidential information that you Register, but Web sites are subject to Utilization Reviews; Establishment of a do not wish to be made available to the change over time.) SPL is a Health Level Public Docket; Request for Comments public, submit the comment as a 7 data standard used by FDA since AGENCY: Food and Drug Administration, written/paper submission and in the 2005. For more information on how HHS. manner detailed (see ‘‘Written/Paper FDA interprets section 745A(a) of the ACTION: Notice, establishment of a Submissions’’ and ‘‘Instructions’’). FD&C Act, see the guidance for industry public docket; request for comments. ‘‘Providing Regulatory Submissions in Written/Paper Submissions mstockstill on DSK30JT082PROD with NOTICES Electronic Format—Submissions Under SUMMARY: The Food and Drug Submit written/paper submission as Section745A(a) of the Federal Food, Administration (FDA) is establishing a follows: Drug, and Cosmetic Act’’ (available at public docket to collect comments • Mail/Hand delivery/Courier (for http://www.fda.gov/downloads/Drugs/ related to the pediatric post-marketing written/paper submissions): Dockets GuidanceComplianceRegulatory pharmacovigilance and drug utilization Management Staff (HFA–305), Food and Information/Guidances/ reviews of products posted between Drug Administration, 5630 Fishers UCM384686.pdf). March 11, 2017, and September 12, Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 17:43 Sep 01, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\05SEN1.SGM 05SEN1

41970 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices • For written/paper comments and/or go to the Dockets Management 5. EMSAM (selegiline transdermal submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, system) Staff, FDA will post your comment, as Rockville, MD 20852. 6. LATISSE (bimatoprost ophthalmic well as any attachments, except for FOR FURTHER INFORMATION CONTACT: solution) 0.03% information submitted, marked and Kenneth Quinto, Office of the 7. NAMENDA (memantine identified, as confidential, if submitted Commissioner, Food and Drug hydrochloride) and NAMENDA XR as detailed in ‘‘Instructions.’’ Administration, 10903 New Hampshire (memantine hydrochloride) Instructions: All submissions received Ave., Bldg. 32, Rm. 5145, Silver Spring, extended-release must include the Docket No. FDA– MD 20993, 240–402–2221, email: 8. PRIFTIN (rifapentine) 2017–N–4866 for the ‘‘Pediatric Post- 9. REYATAZ (atazanavir) kenneth.quinto@fda.hhs.gov. 10. TACLONEX (betamethasone Marketing Pharmacovigilance and Drug SUPPLEMENTARY INFORMATION: FDA is dipropionate/calcipotriene hydrate) Utilization Reviews’’ that have been posted on FDA’s Web site between responsible for protecting the public Topical Suspension 0.064%/ March 11, 2017, and September 12, health by assuring the safety, efficacy, 0.005% and TACLONEX 2017, but not presented at the and security of human and veterinary (betamethasone dipropionate/ September 12, 2017, PAC meeting. drugs, biological products, medical calcipotriene hydrate) Topical Received comments, those filed in a devices, our Nation’s food supply, Ointment 0.064%/0.005% timely manner (see ADDRESSES), will be cosmetics, and products that emit 11. ZETONNA (ciclesonide) placed in the docket and, except for radiation. Dated: August 30, 2017. those submitted as ‘‘Confidential FDA is establishing a public docket, Anna K. Abram, Submissions,’’ publicly viewable at Docket No. FDA–2017–N–4866, to receive input on pediatric post- Deputy Commissioner for Policy, Planning, https://www.regulations.gov or at the Legislation, and Analysis. Dockets Management Staff office marketing pharmacovigilance and drug utilization reviews posted between [FR Doc. 2017–18690 Filed 9–1–17; 8:45 am] between 9 a.m. and 4 p.m., Monday through Friday. March 11, 2017, and September 12, BILLING CODE 4164–01–P • Confidential Submissions—To 2017, available on FDA’s Web site at submit a comment with confidential https://www.fda.gov/ AdvisoryCommittees/ DEPARTMENT OF HEALTH AND information that you do not wish to be HUMAN SERVICES made publicly available, submit your CommitteesMeetingMaterials/ comments only as a written/paper PediatricAdvisoryCommittee/ National Institutes of Health submission. You should submit two ucm510701.htm, but not presented at copies total. One copy will include the the September 12, 2017, PAC meeting. Prospective Grant of an Exclusive information you claim to be confidential FDA welcomes comments by members Patent License: Apparatus for with a heading or cover note that states of the PAC, as mandated by the Best Microarray Binding Sensors Having ‘‘THIS DOCUMENT CONTAINS Pharmaceuticals for Children Act (Pub. Biological Probe Materials Using CONFIDENTIAL INFORMATION.’’ The L. 107–109) and the Pediatric Research Carbon Nanotube Transistors Agency will review this copy, including Equity Act (Pub. L. 108–155), interested the claimed confidential information, in parties (such as academic researchers, AGENCY: National Institutes of Health, its consideration of comments. The regulated industries, consortia, and HHS. second copy, which will have the patient groups), and the general public. ACTION: Notice. claimed confidential information The docket number is FDA–2017–N– SUMMARY: The National Cancer Institute, redacted/blacked out, will be available 4866. The docket will open on October an institute of the National Institutes of for public viewing and posted on 9, 2017, and remain open until October Health, Department of Health and https://www.regulations.gov. Submit 20, 2017. These pediatric post- Human Services, is contemplating the both copies to the Dockets Management marketing pharmacovigilance and drug grant of an Exclusive Commercialization Staff. If you do not wish your name and utilization reviews are for the following Patent License to practice the inventions contact information to be made publicly products from the following centers at embodied in the Patents and Patent available, you can provide this FDA: Applications listed in the information on the cover sheet and not Center for Biologics Evaluation and SUPPLEMENTARY INFORMATION section of in the body of your comments and you Research this notice to Nanobernetics, LLC must identify this information as ‘‘confidential.’’ Any information marked 1. GRASTEK (Timothy Grass Pollen (‘‘Nanobernetics’’) located in Maryland. as ‘‘confidential’’ will not be disclosed Allergen Extract) Tablet for DATES: Only written comments and/or except in accordance with 21 CFR 10.20 Sublingual Use applications for a license which are and other applicable disclosure law. For 2. ORALAIR (Sweet Vernal, Orchard, received by the National Cancer more information about FDA’s posting Perennial Rye, Timothy, and Institute’s Technology Transfer Center of comments to public dockets, see 80 Kentucky Blue Grass Mixed Pollens on or before September 20, 2017 will be FR 56469, September 18, 2015, or access Allergen Extract) Tablet for considered. the information at: https://www.gpo.gov/ Sublingual Use ADDRESSES: Requests for copies of the fdsys/pkg/FR-2015-09-18/pdf/2015- patent application, inquiries, and Center for Drug Evaluation and comments relating to the contemplated 23389.pdf. Docket: For access to the docket to Research Exclusive Commercialization Patent mstockstill on DSK30JT082PROD with NOTICES read background documents or the 1. ALOXI (palonosetron hydrochloride) License should be directed to: Jaime M. electronic and written/paper comments 2. ARNUITY ELLIPTA (fluticasone Greene, Senior Licensing and Patenting received, go to https:// furoate) Manager, NCI Technology Transfer www.regulations.gov and insert the 3. ASMANEX HFA and ASMANEX Center, 9609 Medical Center Drive, Rm. docket number, found in brackets in the TWISTHALER (mometasone furoate 1E530 MSC 9702, Bethesda, MD 20892– heading of this document, into the inhalation) 9702 (for business mail), Rockville, MD ‘‘Search’’ box and follow the prompts 4. CYMBALTA (duloxetine) 20850–9702 Telephone: (240)-276–5530; VerDate Sep<11>2014 17:43 Sep 01, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\05SEN1.SGM 05SEN1


Document Created: 2017-09-02 03:25:17
Document Modified: 2017-09-02 03:25:17
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 October 20, 2017.
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: [email protected]
FR Citation82 FR 41969 
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