[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1469-1470]
[FR Doc No: 2019-00847]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-P-1877 and FDA-2018-P-3730]

Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ESBRIET (pirfenidone), film coated tablets, 534
milligrams (mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for pirfenidone, film coated tablets, 534
mg, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ESBRIET (pirfenidone), film coated tablets, 534 mg, is the subject
of NDA 208780, held by Genentech, Inc., and initially approved on
January 11, 2017. ESBRIET is indicated for the treatment of idiopathic
pulmonary fibrosis. ESBRIET (pirfenidone), film coated tablets, 534 mg,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book. Laurus Labs Ltd. submitted a citizen petition dated
May 14, 2018 (Docket No. FDA-2018-P-1877), and Aziant Drug Research
Solutions Pvt. Ltd. Submitted a citizen petition dated October 1, 2018
(FDA-2018-P-3730), under 21 CFR 10.30, requesting that the Agency
determine whether ESBRIET (pirfenidone), film coated tablets, 534 mg,
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec.  314.161 that ESBRIET (pirfenidone), film coated
tablets, 534 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ESBRIET (pirfenidone), film coated
tablets, 534 mg, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would indicate that this drug product
was withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ESBRIET
(pirfenidone), film coated tablets, 534 mg, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug

products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to this drug product,
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00847 Filed 2-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18135-18136]
[FR Doc No: 2023-06241]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0104; FRL-10577-01-OCSPP]

Safer Choice Partner of the Year Awards for 2023; Call for
Submissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Safer Choice program in the Environmental Protection
Agency (EPA) is accepting submissions for its 2023 Safer Choice Partner
of the Year Awards. EPA developed the Partner of the Year Awards to
recognize the leadership contributions of Safer Choice partners and
stakeholders who have shown achievement in the design, manufacture,
selection, and use of products with safer chemicals, that further
outstanding or innovative source reduction. Similar achievement in the
design, manufacture, selection, and use of Design for the Environment
(DfE) -certified products will also make an organization eligible for
the Partner of the Year Awards. EPA especially encourages submission of
award applications that show how the applicant's work in the design,
manufacture, selection, and use of those products promotes
environmental justice, bolsters resilience to the impacts of climate
change, results in cleaner air or water, improves drinking water
quality, or advances innovation in packaging.

DATES: Submissions are due on or before May 31, 2023.

ADDRESSES: Please submit materials by email to [email protected] and
copy [email protected]. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2019-0104,
is available at https://www.regulations.gov. Candidates interested in
learning more about the Partner of the Year Awards should refer to the
Safer Choice website at https://www.epa.gov/saferchoice/safer-choice-partner-year-awards.

FOR FURTHER INFORMATION CONTACT: Aerin Kirk, Data Gathering and
Analysis Division, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Mail Code 7406M, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you are a Safer Choice
program partner or stakeholder. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Affected entities may include:
     Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
     All Other Basic Organic Chemical Manufacturing (Primary)
(NAICS code 325199);
     Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320);
     Paint and Coating Manufacturing (NAICS code 325510);
     Adhesive Manufacturing (NAICS code 325520);
     Soap and Other Detergent Manufacturing (NAICS code
325611);
     Polish and Other Sanitation Good Manufacturing (NAICS code
325612);
     Surface Active Agent Manufacturing (Primary) (NAICS code
325613);
     Toilet Preparation Manufacturing (NAICS code 325620);
     Photographic Film, Paper, Plate, and Chemical
Manufacturing (NAICS code 325992);
     All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
     Service Establishment Equipment and Supplies Merchant
Wholesalers (Primary) (NAICS code 423850);
     Other Chemical and Allied Products Merchant Wholesalers
(Primary) (NAICS code 424690);
     Supermarkets and Other Grocery (except Convenience) Stores
(Primary) (NAICS code 445110);
     All Other Specialty Food Stores (NAICS code 445299);
     Pharmacies and Drug Stores (NAICS code 446110);
     Office Supplies and Stationery Stores (NAICS code 453210);
     All Other Miscellaneous Store Retailers (except Tobacco
Stores) (Primary) (NAICS code 453998);
     Electronic Shopping and Mail-Order Houses (NAICS code
454110);
     Research and Development in Biotechnology (except
Nanobiotechnology) (Primary) (NAICS code 541714);
     Facilities Support Services (NAICS code 561210).
Janitorial Services (NAICS code 561720);
     Carpet and Upholstery Cleaning Services (NAICS code
561740);
     Elementary and Secondary Schools (NAICS code 611110);
     Colleges, Universities, and Professional Schools (NAICS
code 611310);
     Promoters of Performing Arts, Sports, and Similar Events
with Facilities (NAICS code 711310);
     Drycleaning and Laundry Services (NAICS code 8123);
     Civic and Social Organizations (Primary) (NAICS code
813410);
     Business Associations (Primary) (NAICS code 813910);
     Other General Government Support (NAICS code 921190); and
     Administration of Air and Water Resource and Solid Waste
Management Programs (Primary) (NAICS code 924110).

B. What is the Safer Choice program?

    As part of its environmental mission, the Safer Choice program
partners with businesses to help consumers and commercial buyers
identify products with safer chemical ingredients, without sacrificing
quality or performance. The Safer Choice program certifies products
containing ingredients that have met the program's specific and
rigorous human health and environmental toxicological criteria. The
Safer Choice program allows companies to use its label on certified
products that contain safer ingredients and perform, as determined by
expert evaluation. The Safer Choice program certification represents a
high level of achievement in formulating products that are safer for
people and the environment. For more information on the Safer Choice
program, please see: https://www.epa.gov/saferchoice.

C. What is the DfE program?

    The DfE program is a companion program to Safer Choice and
certifies antimicrobial products. The DfE logo may be used on certified
products and helps consumers and commercial buyers identify products
that meet the health and safety standards of the pesticide registration
process required by the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) as well as the Safer Choice program's stringent criteria
for efficacy and effects on human health and the environment. For more
information on the DfE program, please see: https://www.epa.gov/pesticide-labels/learn-about-design-environment-dfe-certification.

D. What is the purpose of the award?

    The purpose of the Partner of the Year Awards is to recognize the
leadership contributions of Safer Choice program partners and
stakeholders who, over the past year, have shown achievement in the
design, manufacture, selection, and use of products with safer
chemicals, that further outstanding or innovative source reduction. EPA
especially encourages submission of award applications that show how
the applicant's work in the design, manufacture, selection, and use of
those products promotes environmental justice, bolsters resilience to
the impacts of climate change, results in cleaner air or water,
improves drinking water quality, or advances innovation in packaging.
Similar achievement in the design, manufacture, selection, and use of
DfE-certified products will also make an organization eligible for the
Partner of the Year Awards.

E. How can I participate?

    All Safer Choice stakeholders and program participants in good
standing are eligible for recognition. Interested parties who would
like to be considered for this award should submit to EPA an
application detailing their accomplishments and contributions during
calendar year 2022. The application form is available on the Safer
Choice website. Candidates interested in learning more about the
Partner of the Year Awards should refer to the following link: https://www.epa.gov/saferchoice/safer-choice-partner-year-awards. EPA will
recognize award winners at a Safer Choice Partner of the Year Awards
ceremony in the fall of 2023.
    Authority: 42 U.S.C. 13103(b)(13) and 15 U.S.C. 2609.

    Dated: March 17, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-06241 Filed 3-24-23; 8:45 am]
BILLING CODE 6560-50-P