83 FR 11143 - Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases)
SOCIAL SECURITY ADMINISTRATION Federal Register Volume 83, Issue 50 (March 14, 2018)
Federal Register Volume 83, Issue 50 (March 14, 2018)
| Page Range | 11143-11143 | |
| FR Document | 2018-05240 |
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)] [Rules and Regulations] [Page 11143] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05240] ======================================================================= ----------------------------------------------------------------------- SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases) CFR Correction 0 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
![Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations 11143
■ 2. Section 101.5 is amended by adding (d) Use of stability-indicating assay. Done in Washington, DC, this 9th day of
paragraph(s) to read as follows: Stability studies must be conducted March 2018.
with a stability-indicating assay, with Kevin Shea,
§ 101.5 Testing terminology. the following exceptions: Administrator, Animal and Plant Health
* * * * * Inspection Service.
(1) If the potency test specified in the
(s) Stability-indicating assay. A [FR Doc. 2018–05143 Filed 3–13–18; 8:45 am]
filed Outline of Production of a licensed
stability-indicating assay is a validated
product is the one stated in the BILLING CODE 3410–34–P
quantitative analytical procedure that
regulations, that potency test may be
can detect changes over time in a
used in place of a stability-indicating
pertinent property of the product. SOCIAL SECURITY ADMINISTRATION
assay for that fraction.
PART 114—PRODUCTION (2) If the initial confirmation of dating 20 CFR Part 404
REQUIREMENTS FOR BIOLOGICAL study of a product in development on
PRODUCTS April 13, 2018 has an approved potency Revised Medical Criteria for Evaluating
assay, that assay may be used. Cancer (Malignant Neoplastic
■ 3. The authority citation for part 114
(e) Number of serials. At least three Diseases)
continues to read as follows:
production serials of the product shall
Authority: 21 U.S.C. 151–159; 7 CFR 2.22, CFR Correction
be selected for testing in the stability
2.80, and 371.4. study. ■ In Title 20 of the Code of Federal
■ 4. Section 114.12 is revised to read as (f) Testing sequences—(1) Initial test. Regulations, Parts 400 to 499, revised as
follows: The first test in the sequence shall be as of April 1, 2017, on page 541, in Part
close as practical to the day of filling 404, Subpart P, Appendix 1, under
§ 114.12 Expiration date required for a
serial. into final containers or the date of final 13.02, paragraph B., the second ‘‘OR’’ is
formulation if the potency of the removed and under 13.03, paragraphs
Unless otherwise provided for in a B.1. and B.2. are removed.
Standard Requirement or filed Outline product is tested in bulk form.
[FR Doc. 2018–05240 Filed 3–13–18; 8:45 am]
of Production, each serial or subserial of (2) Subsequent testing for in vitro
a biological product prepared in a assays. (i) One test every 3 months BILLING CODE 1301–00–D
licensed establishment shall be given an during the first year of storage;
expiration date according to the dating (ii) One test every 6 months during
period of the product when computed DEPARTMENT OF HEALTH AND
the second year of storage; and
from a date no later than the date of the HUMAN SERVICES
initiation of the first potency test of the (iii) One test annually thereafter
serial or subserial. A licensed biological throughout the proposed dating period. Food and Drug Administration
product shall be considered worthless (3) Subsequent testing for in vivo
under the Virus-Serum-Toxin Act after assays. One test at the end of the 21 CFR Part 864
the expiration date appearing on the proposed dating period. [Docket No. FDA–2018–N–0399]
label. (g) When to conduct a stability study.
■ 5. Section 114.13 is revised to read as Stability studies must be conducted for Medical Devices; Hematology and
follows: the following: Pathology Devices; Classification of
Lynch Syndrome Test Systems;
§ 114.13 Determination of the dating (1) Newly licensed products whose Correction
period of a product. dating has not been confirmed;
The following requirements do not (2) Licensed products with confirmed AGENCY: Food and Drug Administration,
apply to those biological products used dating but a major change to the product HHS.
for diagnostic purposes. or to the potency test has occurred; and ACTION: Final order; correction.
(a) Stability criteria. Stability criteria (3) Licensed products with confirmed SUMMARY: The Food and Drug
include the specifications for potency at dating in which a change in one or more Administration is correcting a final
release, potency throughout the dating of the stability criteria is requested. order entitled ‘‘Medical Devices;
period, and the length of the dating
(h) Submitting data. At the Hematology and Pathology Devices;
period.
completion of the real-time stability Classification of Lynch Syndrome Test
(b) Stability study requirement. The
study to confirm or change the dating Systems’’ that appeared in the Federal
dating period of each fraction of each
period, the data shall be submitted to Register of February 27, 2018. The
product shall be confirmed by
Animal and Plant Health Inspection document was published with the
conducting a stability study.
Service for approval for filing and the incorrect docket number. This
(c) Licensure prior to completion of a
approved for filing date shall be document corrects that error.
stability study. Prior to licensure, the
licensee shall propose a dating period specified in section VI of the filed DATES: Effective March 14, 2018.
for the product based on preliminary Outline of Production at the next FOR FURTHER INFORMATION CONTACT: Lisa
information available about the stability revision. Granger, Office of Policy and Planning,
of each of its fractions. If the (i) Monitoring stability of the product. Food and Drug Administration, 10903
preliminary stability information is For products licensed subsequent to New Hampshire Ave., Bldg, 32, Rm.
acceptable, the product may be licensed April 13, 2018, the licensee or permittee 3330, Silver Spring, MD 20993–0002,
daltland on DSKBBV9HB2PROD with RULES
with the provision that the proposed shall submit a plan to monitor the 301–796–9115.
dating period must be confirmed by stability of the product and the SUPPLEMENTARY INFORMATION: In the
conducting a real-time stability study suitability of its dating period that Federal Register of February 27, 2018
with a stability-indicating potency assay includes regularly testing selected (83 FR 8355), in FR Doc. 2018–03924,
that can detect changes over time in the serials for potency during and at the end on page 8355, the following correction
potency of the product. of dating. is made:
VerDate Sep<11>2014 16:14 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1](https://thefederalregister.org/doc/83_FR_11193/page/1.svg)
Document Created: 2018-03-14 01:06:36
Document Modified: 2018-03-14 01:06:36
| 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 | Rules and Regulations | |
| FR Citation | 83 FR 11143 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR