83 FR 58259 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 223 (November 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 223 (November 19, 2018)
| Page Range | 58259-58260 | |
| FR Document | 2018-25128 |
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)] [Notices] [Pages 58259-58260] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25128] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3771] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA's ``Postmarketing Requirements and Commitments: Reports'' web page (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm). FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to publish an annual report on the status of postmarketing study commitments that applicants have committed to, or are required to conduct, and for which annual status reports have been submitted. Under Sec. Sec. 314.81(b)(2)(vii) and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70), applicants of approved drugs and licensed biologics are required to submit annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study or clinical trial either required by FDA (PMRs) or that they have committed to conduct (PMCs), either at the time of approval or after approval of their new drug application, abbreviated new drug application, or biologics license application. The status of PMCs concerning chemistry, manufacturing, and production controls and the status of other studies or clinical trials conducted on an applicant's own initiative are not required to be reported under Sec. Sec. 314.81(b)(2)(vii) and 601.70 and are not addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report periodically on the status of each required study or clinical trial and each study or clinical trial ``otherwise undertaken . . . to investigate a safety issue . . .'' An applicant must report on the progress of the PMR/PMC on the anniversary of the drug product's approval\1\ until the PMR/PMC is completed or terminated and FDA determines that the PMR/PMC has been fulfilled or that the PMR/PMC is either no longer feasible or would no longer provide useful information. --------------------------------------------------------------------------- \1\ An applicant must submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or on an alternate reporting date that was granted by FDA in writing. Some applicants have requested and been granted by FDA alternate annual reporting dates to facilitate harmonized reporting across multiple applications. --------------------------------------------------------------------------- II. Fiscal Year 2017 Report With this notice, FDA is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Information in this report covers any PMR/PMC that was established, in writing, at the time of approval or after approval of an application or a supplement to an application, and summarizes the status of PMRs/PMCs in fiscal year (FY) 2017 (i.e., as of September 30, 2017). Information summarized in the report reflects combined data from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and includes the following: (1) The number of applicants with open PMRs/PMCs; (2) the number of open PMRs/ PMCs; (3) the timeliness of applicant submission of the annual status reports [[Page 58260]] (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in Sec. 314.81(b)(2)(vii) or Sec. 601.70 ASRs; (5) the status of closed PMRs/ PMCs; and (6) the distribution of the status by fiscal year of establishment \2\ (FY2011 to FY2017) for PMRs and PMCs open at the end of FY2017, or those closed within FY2017. Additional information about PMRs/PMCs is provided on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm. --------------------------------------------------------------------------- \2\ The establishment date is the date of the formal FDA communication to the applicant that included the final FDA-required (PMR) or -requested (PMC) postmarketing study or clinical trial. Dated: November 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25128 Filed 11-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58259
Applica- Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
tion No.
ANDA HYTONE ....................... Hydrocortisone .............. 1%, 2.5% ....................... Cream; Topical .............. Valeant Pharmaceuticals
080472. North America, LLC.
ANDA HYTONE ....................... Hydrocortisone .............. 1%; 2.5% ....................... Lotion; Topical ............... Valeant Pharmaceuticals
080473. North America, LLC.
ANDA HYTONE ....................... Hydrocortisone .............. 1%, 2.5% ....................... Ointment; Topical .......... Dermik Laboratories,
080474. Inc.
NDA SUPRENZA ................... Phentermine HCl ........... 15 mg; 30 mg; 37.5 mg Orally Disintegrating Citius Pharmaceuticals,
202088. Tablet; Oral. LLC.
FDA has reviewed its records and, Food, Drug, and Cosmetic Act (FD&C and the status of other studies or
under § 314.161, has determined that Act), FDA is required to report annually clinical trials conducted on an
the drug products listed were not on the status of postmarketing applicant’s own initiative are not
withdrawn from sale for reasons of requirements (PMRs) and postmarketing required to be reported under
safety or effectiveness. Accordingly, the commitments (PMCs) required of, or §§ 314.81(b)(2)(vii) and 601.70 and are
Agency will continue to list the drug agreed upon by, application holders of not addressed in this report.
products in the ‘‘Discontinued Drug approved drug and biological products. Furthermore, section 505(o)(3)(E) of the
Product List’’ section of the Orange The report on the status of the studies FD&C Act (21 U.S.C. 355(o)(3)(E))
Book. The ‘‘Discontinued Drug Product and clinical trials that applicants have requires that applicants report
List’’ identifies, among other items, drug agreed to, or are required to, conduct is periodically on the status of each
products that have been discontinued on the FDA’s ‘‘Postmarketing required study or clinical trial and each
from marketing for reasons other than Requirements and Commitments: study or clinical trial ‘‘otherwise
safety or effectiveness. Reports’’ web page (https:// undertaken . . . to investigate a safety
Approved ANDAs that refer to the www.fda.gov/Drugs/ issue . . .’’
NDAs and ANDAs listed are unaffected GuidanceCompliance An applicant must report on the
by the discontinued marketing of the RegulatoryInformation/Post-marketing progress of the PMR/PMC on the
products subject to those NDAs and PhaseIVCommitments/ucm064436.htm). anniversary of the drug product’s
ANDAs. Additional ANDAs that refer to FOR FURTHER INFORMATION CONTACT: approval1 until the PMR/PMC is
these products may also be approved by Cathryn C. Lee, Center for Drug completed or terminated and FDA
the Agency if they comply with relevant Evaluation and Research, Food and determines that the PMR/PMC has been
legal and regulatory requirements. If Drug Administration, 10903 New fulfilled or that the PMR/PMC is either
FDA determines that labeling for these Hampshire Ave., Bldg. 22, Rm. 6484, no longer feasible or would no longer
drug products should be revised to meet Silver Spring, MD 20993–0002, 301– provide useful information.
current standards, the Agency will 796–0700; or Stephen Ripley, Center for II. Fiscal Year 2017 Report
advise ANDA applicants to submit such Biologics Evaluation and Research,
labeling. With this notice, FDA is announcing
Food and Drug Administration, 10903
the availability of the Agency’s annual
Dated: November 13, 2018. New Hampshire Ave., Bldg. 71, Rm.
report entitled ‘‘Report on the
Leslie Kux, 7301, Silver Spring, MD 20993–0002,
Performance of Drug and Biologics
Associate Commissioner for Policy.
240–402–7911.
Firms in Conducting Postmarketing
SUPPLEMENTARY INFORMATION: Requirements and Commitments.’’
[FR Doc. 2018–25187 Filed 11–16–18; 8:45 am]
BILLING CODE 4164–01–P I. Background Information in this report covers any
Section 506B(c) of the FD&C Act (21 PMR/PMC that was established, in
U.S.C. 356b(c)) requires FDA to publish writing, at the time of approval or after
DEPARTMENT OF HEALTH AND approval of an application or a
an annual report on the status of
HUMAN SERVICES supplement to an application, and
postmarketing study commitments that
applicants have committed to, or are summarizes the status of PMRs/PMCs in
Food and Drug Administration fiscal year (FY) 2017 (i.e., as of
required to conduct, and for which
[Docket No. FDA–2018–N–3771] annual status reports have been September 30, 2017). Information
submitted. summarized in the report reflects
Report on the Performance of Drug Under §§ 314.81(b)(2)(vii) and 601.70 combined data from the Center for Drug
and Biologics Firms in Conducting (21 CFR 314.81(b)(2)(vii) and 601.70), Evaluation and Research and the Center
Postmarketing Requirements and applicants of approved drugs and for Biologics Evaluation and Research
Commitments; Availability licensed biologics are required to submit and includes the following: (1) The
annually a report on the status of each number of applicants with open PMRs/
AGENCY: Food and Drug Administration,
clinical safety, clinical efficacy, clinical PMCs; (2) the number of open PMRs/
HHS.
pharmacology, and nonclinical PMCs; (3) the timeliness of applicant
ACTION: Notice of availability. submission of the annual status reports
toxicology study or clinical trial either
SUMMARY: The Food and Drug required by FDA (PMRs) or that they
khammond on DSK30JT082PROD with NOTICES
1 An applicant must submit an annual status
Administration (FDA or Agency) is have committed to conduct (PMCs), report on the progress of each open PMR/PMC
announcing the availability of the either at the time of approval or after within 60 days of the anniversary date of U.S.
Agency’s annual report entitled ‘‘Report approval of their new drug application, approval of the original application or on an
on the Performance of Drug and abbreviated new drug application, or alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
Biologics Firms in Conducting biologics license application. The status granted by FDA alternate annual reporting dates to
Postmarketing Requirements and of PMCs concerning chemistry, facilitate harmonized reporting across multiple
Commitments.’’ Under the Federal manufacturing, and production controls applications.
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![58260 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
(ASRs); (4) FDA-verified status of open In 2018, MEPS–IC, available at information and information about the
PMRs/PMCs reported in www.meps.ahrq.gov, published the ACIM can be obtained by accessing:
§ 314.81(b)(2)(vii) or § 601.70 ASRs; (5) annual 2017 average total single https://www.hrsa.gov/advisory-
the status of closed PMRs/PMCs; and (6) premium per enrolled employee at committees/infant-mortality/index.html.
the distribution of the status by fiscal private-sector establishments that FOR FURTHER INFORMATION CONTACT:
year of establishment 2 (FY2011 to provide health insurance. The figure David S. de la Cruz, Ph.D., MPH,
FY2017) for PMRs and PMCs open at published was $6,368. This figure is Designated Federal Official (DFO), at
the end of FY2017, or those closed divided by 12 months to determine the HRSA, Maternal and Child Health
within FY2017. Additional information cost per month of $530.67. The $530.67 Bureau (MCHB), 5600 Fishers Lane,
about PMRs/PMCs is provided on FDA’s figure is increased or decreased by the Rockville, Maryland 20857; 301–443–
website at https://www.fda.gov/Drugs/ percentage change reported by the most 0543; or dcruz@hrsa.gov.
GuidanceCompliance recent KFF Employer Health Benefits SUPPLEMENTARY INFORMATION: ACIM
RegulatoryInformation/Post-marketing Survey, available at www.kff.org. The provides advice and recommendations
PhaseIVCommitments/default.htm. percentage increase from 2017 to 2018 to the Secretary of HHS (Secretary) on
Dated: November 13, 2018. was 3.0 percent. By adding this HHS programs and activities that focus
Leslie Kux, percentage increase, the calculated on reducing infant mortality and
average monthly cost of a health improving the health status of infants
Associate Commissioner for Policy.
insurance policy for a 12-month period and pregnant women and factors
[FR Doc. 2018–25128 Filed 11–16–18; 8:45 am]
is $546.59. affecting the continuum of care with
BILLING CODE 4164–01–P Therefore, the Secretary announces
respect to maternal and child health
that the revised average cost of a health
care. ACIM focuses on outcomes before,
insurance policy under the VICP is
DEPARTMENT OF HEALTH AND during, and following pregnancy and
$546.59 per month. In accordance with
HUMAN SERVICES childbirth, strategies to coordinate a
§ 100.2, the revised amount was
myriad of federal, state, local, and
Health Resources and Services effective upon its delivery by the
private programs, efforts that are
Administration Secretary to the Court. Such notice was
designed to deal with the health and
delivered to the Court on November 13,
social problems impacting infant
National Vaccine Injury Compensation 2018.
mortality, and the implementation of
Program: Revised Amount of the Dated: November 13, 2018. the federal Healthy Start Program.
Average Cost of a Health Insurance George Sigounas, The meeting agenda is being finalized
Policy Administrator. and tentatively includes updates on
AGENCY: Health Resources and Services [FR Doc. 2018–25087 Filed 11–16–18; 8:45 am] HRSA, MCHB, and the Healthy Start
Administration (HRSA), Department of BILLING CODE 4165–15–P Program, an introduction of members, a
Health and Human Services (HHS). briefing on infant mortality and health
ACTION: Notice. disparity data in the U.S., and future
DEPARTMENT OF HEALTH AND topic areas for ACIM to discuss. Agenda
SUMMARY: HRSA is publishing an HUMAN SERVICES items are subject to changes as priorities
updated monetary amount of the dictate. The final meeting agenda will
average cost of a health insurance policy Health Resources and Service be available 2 days prior to the meeting
as it relates to the National Vaccine Administration on the ACIM website: https://
Injury Compensation Program (VICP). www.hrsa.gov/advisory-committees/
SUPPLEMENTARY INFORMATION: Section Meeting of the Advisory Committee on
Infant-Mortality/index.html. Refer to the
100.2 of VICP’s implementing regulation Infant Mortality
ACIM website for any updated
(42 CFR part 100) states that the revised AGENCY: Health Resources and Service information concerning the meeting.
amount of an average cost of a health Administration (HRSA), Department of Members of the public will have the
insurance policy, as determined by the Health and Human Services (HHS). opportunity to provide comments on the
Secretary of HHS (the Secretary), is ACTION: Notice. afternoon of December 5, 2018. Written
effective upon its delivery by the comments must be submitted via email
Secretary to the United States Court of SUMMARY: The Advisory Committee on to the DFO, David S. de la Cruz, by
Federal Claims (the Court), and will be Infant Mortality (ACIM) has scheduled a 12:00 p.m. ET on Tuesday, November
published periodically in a notice in the public meeting. 20, 2018, at dcruz@hrsa.gov. Please
Federal Register. This figure is DATES: December 4, 2018, 9:00 a.m.– indicate if your comments will be
calculated using the most recent 5:00 p.m. ET and December 5, 2018, written only or if you are requesting to
Medical Expenditure Panel Survey- 9:00 a.m.–3:30 p.m. ET. present your comments in person
Insurance Component (MEPS–IC) data ADDRESSES: This meeting will be held during the meeting. All comments (oral
available as the baseline for the average in-person and by webinar. The address and written) will be part of the official
monthly cost of a health insurance for the meeting is 5600 Fishers Lane, meeting record. To ensure all
policy. This baseline is adjusted by the Room 5W11, Rockville, Maryland individuals who have requested time for
annual percentage increase/decrease 20857. Instructions on how to access the oral comments are accommodated, the
obtained from the most recent annual meeting via webcast will be provided allocated time for each comment will be
Kaiser Family Foundation (KFF) limited to no more than 3 minutes. More
khammond on DSK30JT082PROD with NOTICES
upon registration.
Employer Health Benefits Survey or Information about ACIM and the complete/longer comments should be
other authoritative source that may be agenda for this meeting can be found on submitted in writing. Individuals
more accurate or appropriate. the ACIM website at https:// associated with groups or who plan to
www.hrsa.gov/advisory-committees/ provide comments on similar topics
2 The establishment date is the date of the formal
FDA communication to the applicant that included
infant-mortality/index.html. While this may be asked to combine their
the final FDA-required (PMR) or -requested (PMC) meeting is open to the public, advance comments and present them through a
postmarketing study or clinical trial. registration is required. Registration single representative. No audiovisual
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Document Created: 2018-11-17 02:47:16
Document Modified: 2018-11-17 02:47:16
| 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 of availability. | |
| Contact | Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 58259 |
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