Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases), 11143 [2018-05240]Download as PDF
Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations
2. Section 101.5 is amended by adding
paragraph(s) to read as follows:
(s) Stability-indicating assay. A
stability-indicating assay is a validated
quantitative analytical procedure that
can detect changes over time in a
pertinent property of the product.
REQUIREMENTS FOR BIOLOGICAL
3. The authority citation for part 114
continues to read as follows:
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
4. Section 114.12 is revised to read as
Expiration date required for a
Unless otherwise provided for in a
Standard Requirement or filed Outline
of Production, each serial or subserial of
a biological product prepared in a
licensed establishment shall be given an
expiration date according to the dating
period of the product when computed
from a date no later than the date of the
initiation of the first potency test of the
serial or subserial. A licensed biological
product shall be considered worthless
under the Virus-Serum-Toxin Act after
the expiration date appearing on the
■ 5. Section 114.13 is revised to read as
daltland on DSKBBV9HB2PROD with RULES
§ 114.13 Determination of the dating
period of a product.
The following requirements do not
apply to those biological products used
for diagnostic purposes.
(a) Stability criteria. Stability criteria
include the specifications for potency at
release, potency throughout the dating
period, and the length of the dating
(b) Stability study requirement. The
dating period of each fraction of each
product shall be confirmed by
conducting a stability study.
(c) Licensure prior to completion of a
stability study. Prior to licensure, the
licensee shall propose a dating period
for the product based on preliminary
information available about the stability
of each of its fractions. If the
preliminary stability information is
acceptable, the product may be licensed
with the provision that the proposed
dating period must be confirmed by
conducting a real-time stability study
with a stability-indicating potency assay
that can detect changes over time in the
potency of the product.
16:14 Mar 13, 2018
(d) Use of stability-indicating assay.
Stability studies must be conducted
with a stability-indicating assay, with
the following exceptions:
(1) If the potency test specified in the
filed Outline of Production of a licensed
product is the one stated in the
regulations, that potency test may be
used in place of a stability-indicating
assay for that fraction.
(2) If the initial confirmation of dating
study of a product in development on
April 13, 2018 has an approved potency
assay, that assay may be used.
(e) Number of serials. At least three
production serials of the product shall
be selected for testing in the stability
(f) Testing sequences—(1) Initial test.
The first test in the sequence shall be as
close as practical to the day of filling
into final containers or the date of final
formulation if the potency of the
product is tested in bulk form.
(2) Subsequent testing for in vitro
assays. (i) One test every 3 months
during the first year of storage;
(ii) One test every 6 months during
the second year of storage; and
(iii) One test annually thereafter
throughout the proposed dating period.
(3) Subsequent testing for in vivo
assays. One test at the end of the
proposed dating period.
(g) When to conduct a stability study.
Stability studies must be conducted for
(1) Newly licensed products whose
dating has not been confirmed;
(2) Licensed products with confirmed
dating but a major change to the product
or to the potency test has occurred; and
(3) Licensed products with confirmed
dating in which a change in one or more
of the stability criteria is requested.
(h) Submitting data. At the
completion of the real-time stability
study to confirm or change the dating
period, the data shall be submitted to
Animal and Plant Health Inspection
Service for approval for filing and the
approved for filing date shall be
specified in section VI of the filed
Outline of Production at the next
(i) Monitoring stability of the product.
For products licensed subsequent to
April 13, 2018, the licensee or permittee
shall submit a plan to monitor the
stability of the product and the
suitability of its dating period that
includes regularly testing selected
serials for potency during and at the end
Done in Washington, DC, this 9th day of
Administrator, Animal and Plant Health
[FR Doc. 2018–05143 Filed 3–13–18; 8:45 am]
BILLING CODE 3410–34–P
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
Revised Medical Criteria for Evaluating
Cancer (Malignant Neoplastic
In Title 20 of the Code of Federal
Regulations, Parts 400 to 499, revised as
of April 1, 2017, on page 541, in Part
404, Subpart P, Appendix 1, under
13.02, paragraph B., the second ‘‘OR’’ is
removed and under 13.03, paragraphs
B.1. and B.2. are removed.
[FR Doc. 2018–05240 Filed 3–13–18; 8:45 am]
BILLING CODE 1301–00–D
DEPARTMENT OF HEALTH AND
Food and Drug Administration
21 CFR Part 864
[Docket No. FDA–2018–N–0399]
Medical Devices; Hematology and
Pathology Devices; Classification of
Lynch Syndrome Test Systems;
Food and Drug Administration,
Final order; correction.
The Food and Drug
Administration is correcting a final
order entitled ‘‘Medical Devices;
Hematology and Pathology Devices;
Classification of Lynch Syndrome Test
Systems’’ that appeared in the Federal
Register of February 27, 2018. The
document was published with the
incorrect docket number. This
document corrects that error.
DATES: Effective March 14, 2018.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg, 32, Rm.
3330, Silver Spring, MD 20993–0002,
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 27, 2018
(83 FR 8355), in FR Doc. 2018–03924,
on page 8355, the following correction
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05240]
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
Revised Medical Criteria for Evaluating Cancer (Malignant
In Title 20 of the Code of Federal Regulations, Parts 400 to 499,
revised as of April 1, 2017, on page 541, in Part 404, Subpart P,
Appendix 1, under 13.02, paragraph B., the second ``OR'' is removed and
under 13.03, paragraphs B.1. and B.2. are removed.
[FR Doc. 2018-05240 Filed 3-13-18; 8:45 am]
BILLING CODE 1301-00-D