Charter Establishment for the Advisory Committee on Heritable Disorders in Newborns and Children, 12933 [2020-04504]
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Federal Register / Vol. 85, No. 44 / Thursday, March 5, 2020 / Notices
approved under section 505 of the FD&C
Act (21 U.S.C. 355). On March 23, 2010,
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148). The BPCI Act clarified the
statutory authority under which certain
protein products will be regulated by
amending the definition of a ‘‘biological
product’’ in section 351(i) of the PHS
Act to include a ‘‘protein (except any
chemically synthesized polypeptide),’’
and describing procedures for
submission of a marketing application
for certain biological products. The
Further Consolidated Appropriations
Act, 2020 (Pub. L. 116–94) further
amended the definition of a ‘‘biological
product’’ in section 351(i) of the PHS
Act to remove the parenthetical
exception for ‘‘any chemically
synthesized polypeptide’’ from the
statutory category of ‘‘protein’’ (see
Division N, section 605, of the Further
Consolidated Appropriations Act, 2020).
Products containing pancreatin or
pancrelipase fall within FDA’s
interpretation of the term ‘‘protein’’ in
the statutory definition of a biological
product (for additional information, see
the final rule entitled ‘‘Definition of the
Term ‘Biological Product’ (85 FR 10057,
February 21, 2020)
The BPCI Act requires that a
marketing application for a ‘‘biological
product’’ (that previously could have
been submitted under section 505 of the
FD&C Act) must be submitted under
section 351 of the PHS Act; this
requirement is subject to certain
exceptions during a 10-year transition
period ending on March 23, 2020 (see
section 7002(e)(1) to (3) and (e)(5) of the
BPCI Act). On March 23, 2020 (i.e., the
transition date), an approved
application for a biological product
under section 505 of the FD&C Act shall
be deemed to be a license for the
biological product under section 351 of
the PHS Act (see section 7002(e)(4)(A)
of the BPCI Act; see also section
7002(e)(4)(B) of the BPCI Act). After
March 23, 2020, all sponsors seeking
approval of a biological product (that
previously could have been submitted
under section 505 of the FD&C Act) will
need to submit a BLA under the PHS
Act (see section 7002(e) of the BPCI
Act). (For additional information, see
FDA’s guidance for industry entitled
‘‘Interpretation of the ‘Deemed to be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009’’ (December 2018), available at
https://www.fda.gov/media/119272/
download.)
FDA is withdrawing the guidance
because a marketing application for a
VerDate Sep<11>2014
16:20 Mar 04, 2020
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proposed PEP that contains the
ingredients pancreatin or pancrelipase
may not be submitted under section 505
of the FD&C Act after March 23, 2020.
The guidance included a description of
data and information that may support
submission of NDAs, including
505(b)(2) applications, for these
products. FDA anticipates that there
will be different considerations that may
inform development of proposed PEPs
intended for submission in BLAs under
section 351 of the PHS Act. FDA intends
to issue guidance regarding how the
concepts described in the withdrawn
guidance would apply to proposed
pancreatic enzyme products submitted
under the PHS Act, including the extent
of integration of various types of data
and information about the use of PEPs
into BLAs. In the interim, the Agency
encourages sponsors interested in
submitting a BLA for a PEP to contact
the relevant review division in the
Office of New Drugs in FDA’s Center for
Drug Evaluation and Research with any
questions.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04531 Filed 3–4–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Establishment for the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act
(FACA), HHS is hereby giving notice
that the Advisory Committee on
Heritable Disorders in Newborns and
Children (ACHDNC) has been
established as a discretionary advisory
committee. The effective date of the
establishment is March 20, 2020.
FOR FURTHER INFORMATION CONTACT: Debi
Sarkar, Designated Federal Official,
Maternal and Child Health Bureau,
HRSA, 5600 Fishers Lane, 18W65,
Rockville, Maryland 20857; 301–443–
0959; or DSarkar@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
ACHDNC provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
SUMMARY:
PO 00000
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12933
concerning certain activities described
in section 1111 of the Public Health
Service (PHS) Act (42 U.S.C. 300b–10),
as further described below. The
ACHDNC will fulfill the functions
previously undertaken by the former
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children, which was established under
the PHS Act, Title XI § 1111(a) (42
U.S.C. 300b-10(a)). The ACHDNC is also
governed by the provisions of the
FACA, as amended (5 U.S.C. App.),
which sets forth standards for the
formation and use of advisory
committees. The ACHDNC advises the
Secretary of HHS about aspects of
newborn and childhood screening and
technical information for the
development of policies and priorities
that will enhance the ability of the state
and local health agencies to provide for
newborn and child screening,
counseling and health care services for
newborns and children having, or at risk
for, heritable disorders. The ACHDNC
will review and report regularly on
newborn and childhood screening
practices, recommend improvements in
the national newborn and childhood
screening programs, as well as fulfill the
list of requirements stated in the
original authorizing legislation. The
ACHDNC charter authorizes the
committee to operate until March 20,
2022. A copy of the ACHDNC charter is
available on the ACHDNC website at
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
index.html. A copy of the charter also
can be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website address for
the FACA database is https://
www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–04504 Filed 3–4–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
SUMMARY:
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Page 12933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04504]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Charter Establishment for the Advisory Committee on Heritable
Disorders in Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act (FACA),
HHS is hereby giving notice that the Advisory Committee on Heritable
Disorders in Newborns and Children (ACHDNC) has been established as a
discretionary advisory committee. The effective date of the
establishment is March 20, 2020.
FOR FURTHER INFORMATION CONTACT: Debi Sarkar, Designated Federal
Official, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane,
18W65, Rockville, Maryland 20857; 301-443-0959; or [email protected]a.gov.
SUPPLEMENTARY INFORMATION: The ACHDNC provides advice and
recommendations to the Secretary of HHS on policy, program development,
and other matters of significance concerning certain activities
described in section 1111 of the Public Health Service (PHS) Act (42
U.S.C. 300b-10), as further described below. The ACHDNC will fulfill
the functions previously undertaken by the former Secretary's Advisory
Committee on Heritable Disorders in Newborns and Children, which was
established under the PHS Act, Title XI Sec. 1111(a) (42 U.S.C. 300b-
10(a)). The ACHDNC is also governed by the provisions of the FACA, as
amended (5 U.S.C. App.), which sets forth standards for the formation
and use of advisory committees. The ACHDNC advises the Secretary of HHS
about aspects of newborn and childhood screening and technical
information for the development of policies and priorities that will
enhance the ability of the state and local health agencies to provide
for newborn and child screening, counseling and health care services
for newborns and children having, or at risk for, heritable disorders.
The ACHDNC will review and report regularly on newborn and childhood
screening practices, recommend improvements in the national newborn and
childhood screening programs, as well as fulfill the list of
requirements stated in the original authorizing legislation. The ACHDNC
charter authorizes the committee to operate until March 20, 2022. A
copy of the ACHDNC charter is available on the ACHDNC website at
https://www.hrsa.gov/advisory-committees/heritable-disorders/. A copy of the charter also can be obtained by accessing the
FACA database that is maintained by the Committee Management
Secretariat under the General Services Administration. The website
address for the FACA database is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-04504 Filed 3-4-20; 8:45 am]
BILLING CODE 4165-15-P
