82 FR 11227 - Pediatric Postmarketing 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 33 (February 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 33 (February 21, 2017)
| Page Range | 11227-11228 | |
| FR Document | 2017-03365 |
[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)] [Notices] [Pages 11227-11228] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-03365] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0595] Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 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 March 10, 2017. The docket will open on February 27, 2017, and remain open until March 10, 2017. ADDRESSES: You may submit your 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, 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-0595 for ``Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews'' that have been posted on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm between September 17, 2016, and February 24, 2017, but will not be presented at the March 6-7, 2017 PAC meeting (82 FR 1345, January 5, 2017). Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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'' [[Page 11228]] 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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: [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 is establishing a public docket FDA-2017-N-0595 to receive input on pediatric postmarketing pharmacovigilance and drug utilization reviews posted between September 17, 2016, and February 24, 2017, on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm, but will not be presented at the March 6-7, 2017, PAC meeting (82 FR 1345, January 5, 2017). 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 will open on February 27, 2017, and remain open until March 10, 2017. These pediatric postmarketing pharmacovigilance and drug utilization reviews are for the following products: ALEVE PM (diphenhydramine hydrochloride/naproxen sodium) ASTEPRO (azelastine hydrochloride) ECOZA (econazole nitrate) JETREA (ocriplasmin) QUARTETTE (levonorgestrel/ethinyl estradiol and ethinyl estradiol) TRUVADA (emtricitabine/tenofovir disoproxil fumarate) XERESE (acyclovir/hydrocortisone) Dated: February 15, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017-03365 Filed 2-17-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices 11227
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
the meeting. Background material is HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
available at http://www.fda.gov/
Food and Drug Administration Written/Paper Submissions
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the Submit written/paper submission as
[Docket No. FDA–2017–N–0595]
appropriate advisory committee meeting follows:
link. Pediatric Postmarketing • Mail/Hand delivery/Courier (for
Pharmacovigilance and Drug written/paper submissions): Division of
Procedure: Interested persons may Dockets Management (HFA–305), Food
present data, information, or views, Utilization Reviews; Establishment of a
Public Docket; Request for Comments and Drug Administration, 5630 Fishers
orally or in writing, on issues pending Lane, Rm. 1061, Rockville, MD 20852.
before the committee. Written AGENCY: Food and Drug Administration, • For written/paper comments
submissions may be made to the contact HHS. submitted to the Division of Dockets
person on or before March 23, 2017. ACTION: Notice; request for comments. Management, FDA will post your
Oral presentations from the public will comment, as well as any attachments,
be scheduled between approximately 1 SUMMARY: The Food and Drug except for information submitted,
p.m. and 2 p.m. Those individuals Administration (FDA or Agency) is marked and identified, as confidential,
interested in making formal oral establishing a public docket to collect if submitted as detailed in
presentations should notify the contact comments related to the pediatric ‘‘Instructions.’’
person and submit a brief statement of postmarketing pharmacovigilance and Instructions: All submissions received
the general nature of the evidence or drug utilization reviews of products must include the Docket No. FDA–
arguments they wish to present, the posted between September 17, 2016, 2017–N–0595 for ‘‘Pediatric
names and addresses of proposed and February 24, 2017, on the FDA Web Postmarketing Pharmacovigilance and
participants, and an indication of the site, but will not be presented at the Drug Utilization Reviews’’ that have
approximate time requested to make March 6–7, 2017, Pediatric Advisory been posted on the FDA Web site at
their presentation on or before March Committee (PAC) meeting. These http://www.fda.gov/
15, 2017. Time allotted for each reviews are intended to be available for AdvisoryCommittees/
presentation may be limited. If the review and comment by members of the CommitteesMeetingMaterials/
number of registrants requesting to PAC, interested parties (such as PediatricAdvisoryCommittee/
speak is greater than can be reasonably academic researchers, regulated ucm510701.htm between September 17,
accommodated during the scheduled industries, consortia, and patient 2016, and February 24, 2017, but will
open public hearing session, FDA may groups), and the general public. not be presented at the March 6–7, 2017
conduct a lottery to determine the DATES: Submit either electronic or PAC meeting (82 FR 1345, January 5,
speakers for the scheduled open public written comments by March 10, 2017. 2017). Received comments will be
hearing session. The contact person will The docket will open on February 27, placed in the docket and, except for
notify interested persons regarding their 2017, and remain open until March 10, those submitted as ‘‘Confidential
request to speak by March 16, 2017. 2017. Submissions,’’ publicly viewable at
Persons attending FDA’s advisory ADDRESSES: You may submit your https://www.regulations.gov or at the
committee meetings are advised that the comments as follows: Division of Dockets Management
Agency is not responsible for providing between 9 a.m. and 4 p.m., Monday
Electronic Submissions through Friday.
access to electrical outlets.
Submit electronic comments in the • Confidential Submissions—To
FDA welcomes the attendance of the following way: submit a comment with confidential
public at its advisory committee • Federal eRulemaking Portal: information that you do not wish to be
meetings and will make every effort to https://www.regulations.gov. Follow the made publicly available, submit your
accommodate persons with disabilities. instructions for submitting comments. comments only as a written/paper
If you require accommodations due to a Comments submitted electronically, submission. You should submit two
disability, please contact Caryn Cohen including attachments, to https:// copies total. One copy will include the
at least 7 days in advance of the www.regulations.gov will be posted to information you claim to be confidential
meeting. the docket unchanged. Because your with a heading or cover note that states
FDA is committed to the orderly comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
conduct of its advisory committee solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
meetings. Please visit our Web site at comment does not include any Agency will review this copy, including
http://www.fda.gov/ confidential information that you or a the claimed confidential information, in
AdvisoryCommittees/ third party may not wish to be posted, its consideration of comments. The
AboutAdvisoryCommittees/ such as medical information, you or second copy, which will have the
ucm111462.htm for procedures on anyone else’s Social Security number, or claimed confidential information
public conduct during advisory confidential business information, such redacted/blacked out, will be available
committee meetings. as a manufacturing process. Please note for public viewing and posted on
Notice of this meeting is given under that if you include your name, contact https://www.regulations.gov. Submit
the Federal Advisory Committee Act (5 information, or other information that both copies to the Division of Dockets
Management. If you do not wish your
sradovich on DSK3GMQ082PROD with NOTICES
U.S.C. app. 2). identifies you in the body of your
comments, that information will be name and contact information to be
Dated: February 15, 2017. posted on https://www.regulations.gov. made publicly available, you can
Janice M. Soreth, • If you want to submit a comment provide this information on the cover
Associate Commissioner for Special Medical with confidential information that you sheet and not in the body of your
Programs. do not wish to be made available to the comments and you must identify this
[FR Doc. 2017–03364 Filed 2–17–17; 8:45 am] public, submit the comment as a information as ‘‘confidential.’’ Any
BILLING CODE 4164–01–P written/paper submission and in the information marked as ‘‘confidential’’
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![11228 Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices
will not be disclosed except in • TRUVADA (emtricitabine/tenofovir Performance Report (NFLP–APR)
accordance with 21 CFR 10.20 and other disoproxil fumarate) Financial Data Form. The form was
applicable disclosure law. For more • XERESE (acyclovir/hydrocortisone) previously titled as the Nurse Faculty
information about FDA’s posting of Dated: February 15, 2017. Loan Program, Annual Operating Report
comments to public dockets, see 80 FR Janice M. Soreth,
(NFLP–AOR).
56469, September 18, 2015, or access Section 846A of the Public Health
Associate Commissioner for Special Medical Service Act provides the Secretary of
the information at: http://www.fda.gov/ Programs.
regulatoryinformation/dockets/ HHS with the authority to enter into an
[FR Doc. 2017–03365 Filed 2–17–17; 8:45 am]
default.htm. agreement with schools of nursing for
BILLING CODE 4164–01–P the establishment and operation of a
Docket: For access to the docket to
read background documents or the student loan fund to increase the
electronic and written/paper comments number of qualified nurse faculty.
DEPARTMENT OF HEALTH AND Under the agreement, HRSA makes
received, go to http://
HUMAN SERVICES awards to schools for the NFLP loan
www.regulations.gov and insert the
docket number, found in brackets in the Health Resources and Services fund, which must be maintained in a
heading of this document, into the Administration distinct account. A school of nursing
‘‘Search’’ box and follow the prompts makes loans from the NFLP account to
and/or go to the Division of Dockets Agency Information Collection students enrolled full-time or, at the
Management, 5630 Fishers Lane, Rm. Activities: Proposed Collection: Public discretion of the Secretary, part-time in
1061, Rockville, MD 20852. Comment Request; Nurse Faculty a master’s or doctoral nursing education
FOR FURTHER INFORMATION CONTACT: Loan Program, Annual Performance program that will prepare them to
Kenneth Quinto, Office of the Report Financial Data Form become qualified nursing faculty.
Commissioner, Food and Drug Following graduation from the NFLP
AGENCY: Health Resources and Services lending school, loan recipients may
Administration, 10903 New Hampshire
Administration (HRSA), Department of receive up to 85 percent NFLP loan
Ave., Bldg. 32, Rm. 5145, Silver Spring,
Health and Human Services (HHS). cancellation over a consecutive 4-year
MD 20993, 240–402–2221, email:
kenneth.quinto@fda.hhs.gov. ACTION: Notice. period in exchange for service as full-
time faculty at a school of nursing. The
SUPPLEMENTARY INFORMATION: FDA is SUMMARY: In compliance with the NFLP lending school collects any
responsible for protecting the public requirement for opportunity for public portion of the loan that is not cancelled
health by assuring the safety, efficacy, comment on proposed data collection and any loans that go into repayment
and security of human and veterinary projects of the Paperwork Reduction Act due to default, and deposits these
drugs, biological products, medical of 1995, HRSA announces plans to monies into the NFLP loan fund to make
devices, our Nation’s food supply, submit an Information Collection additional NFLP loans.
cosmetics, and products that emit Request (ICR), described below, to the Need and Proposed Use of the
radiation. Office of Management and Budget Information: The online NFLP–APR
FDA is establishing a public docket (OMB). Prior to submitting the ICR to Financial Data Form is an online form
FDA–2017–N–0595 to receive input on OMB, HRSA seeks comments from the in the HRSA Electronic Handbooks
pediatric postmarketing public regarding the burden estimate, (EHBs) Performance Report module as
pharmacovigilance and drug utilization below, or any other aspect of the ICR. part of the NFLP, Bureau of Health
reviews posted between September 17, Workforce performance report (OMB
DATES: Comments on this ICR should be
2016, and February 24, 2017, on the No: 0915–0061, expiration date of 6/30/
received no later than April 24, 2017.
FDA Web site at http://www.fda.gov/ 2019). The revised NFLP–APR financial
AdvisoryCommittees/ ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA data form will collect less data from
CommitteesMeetingMaterials/ applicants and will no longer include
PediatricAdvisoryCommittee/ Information Collection Clearance
Officer, 14N39, 5600 Fishers Lane, nursing student demographic data. The
ucm510701.htm, but will not be nursing student demographic data is
presented at the March 6–7, 2017, PAC Rockville, MD 20857.
currently collected under OMB approval
meeting (82 FR 1345, January 5, 2017). FOR FURTHER INFORMATION CONTACT: To number No: 0915–0061. The revised
FDA welcomes comments by members request more information on the NFLP–APR form will only collect
of the PAC, as mandated by the Best proposed project or to obtain a copy of financial data to capture the NFLP loan
Pharmaceuticals for Children Act (Pub. the data collection plans and draft fund account activity related to
L. 107–109) and the Pediatric Research instruments, email paperwork@hrsa.gov financial receivables, disbursements,
Equity Act (Pub. L. 108–155), interested or call the HRSA Information Collection and borrower account data related to
parties (such as academic researchers, Clearance Officer at (301) 443–1984. employment status, loan cancellation,
regulated industries, consortia, and SUPPLEMENTARY INFORMATION: When loan repayment, and collections.
patient groups), and the general public. submitting comments or requesting Participating schools will provide HRSA
The docket will open on February 27, information, please include the with current and cumulative
2017, and remain open until March 10, information request collection title for information on: (1) NFLP loan funds
2017. These pediatric postmarketing reference, in compliance with Section received, (2) number and amount of
pharmacovigilance and drug utilization 3506(c)(2)(A) of the Paperwork NFLP loans made, (3) number and
reviews are for the following products: Reduction Act of 1995.
sradovich on DSK3GMQ082PROD with NOTICES
amount of loans cancelled, (4) number
• ALEVE PM (diphenhydramine Information Collection Request Title: and amount of loans in repayment, (5)
hydrochloride/naproxen sodium) Nurse Faculty Loan Program, Annual loan default rate percent, (6) number of
• ASTEPRO (azelastine hydrochloride) Performance Report Financial Data NFLP graduates employed as nurse
• ECOZA (econazole nitrate) Form, OMB No. 0915–0314—Revision. faculty, and (7) other related loan fund
• JETREA (ocriplasmin) Abstract: This collection request is for costs and activities.
• QUARTETTE (levonorgestrel/ethinyl continued approval of the Nurse Faculty The school of nursing must keep
estradiol and ethinyl estradiol) Loan Program’s revised Annual records of all NFLP loan fund
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Document Created: 2018-02-01 15:04:24
Document Modified: 2018-02-01 15:04:24
| 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; request for comments. | |
| Dates | Submit either electronic or written comments by March 10, 2017. The docket will open on February 27, 2017, and remain open until March 10, 2017. | |
| 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: [email protected] | |
| FR Citation | 82 FR 11227 |
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