83 FR 56857 - Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 220 (November 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 220 (November 14, 2018)
| Page Range | 56857-56859 | |
| FR Document | 2018-24763 |
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)] [Notices] [Pages 56857-56859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24763] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3931] Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' This draft guidance provides recommendations to sponsors regarding the use of metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer (nmCRPC) development programs for drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). DATES: Submit either electronic or written comments on the draft guidance by January 14, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. [[Page 56858]] ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-3931 for ``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240- 402-0489; 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 FDA is announcing the availability of a draft guidance for industry entitled ``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' This draft guidance provides recommendations to sponsors regarding the use of MFS as an endpoint in clinical trials for nmCRPC development programs for drug or biological products regulated by CDER and CBER. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 has been approved under OMB control number 0910-0014. The collections of information in 21 CFR parts 50 and 56 (Protection of Human Subjects: Informed Consent; Institutional Review Boards) have been approved under OMB control number 0910-0755. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. [[Page 56859]] Dated: November 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24763 Filed 11-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices 56857
information are manufacturers of beers information. Two comments were beer for transparency to the consumer.
that are subject to our labeling laws and received. One comment was unrelated We are appreciative of these comments.
regulations. to the Paperwork Reduction Act and is At this time, we do not plan on
In the Federal Register of June 29, not addressed. The second comment adjusting our current estimate.
2018 (83 FR 30738), FDA published a was in favor of the practical utility and FDA estimates the burden of this
60-day notice requesting public necessity of labeling the ingredients of
comment on the proposed collection of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual Total
21 CFR section; activity burden per
respondents per disclosures hours
disclosure
respondent
§§ 101.3 and 101.22; principal display and display 12 2 24 0.5 (30 minutes) .......... 12
panel.
§ 101.4; designation of ingredients ........................ 12 2 24 1 .................................. 24
§ 101.5; name of manufacturer; packer; distributor 12 2 24 0.25 (15 minutes) ........ 6
§ 101.9; nutrition labeling ....................................... 12 2 24 4 .................................. 96
§ 101.7 (formerly 101.105); quantity of contents ... 12 2 24 0.5 (30 minutes) .......... 12
Section 403(w)(1) of the FD&C Act ....................... 12 2 24 1 .................................. 24
Review of Guidance Document: ‘‘Labeling of Cer- 12 1 12 1 .................................. 12
tain Beers Subject to the Labeling Jurisdiction
of the Food and Drug Administration’’.
Total ................................................................ ........................ ........................ ........................ ..................................... 186
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information manufacturers will spend 7.25 hours DEPARTMENT OF HEALTH AND
collection since our last request for (0.5 hours + 1 hour + 0.25 hour + 4 HUMAN SERVICES
OMB approval, we have made no hours + 0.5 hour + 1 hour = 7.25 hours)
adjustments to our burden estimate. Our on each label to comply with our Food and Drug Administration
estimate of the number of respondents labeling regulations and the [Docket No. FDA–2018–D–3931]
is based on the number of regulatory requirements of section 403(w)(1) of the
submissions to TTB for beers that do not FD&C Act, for a total of 174 hours (24 Nonmetastatic, Castration-Resistant
meet the definition of a ‘‘malt beverage’’ labels × 7.25 hours = 174 hours). In Prostate Cancer: Considerations for
under the FAA Act. Based on its records addition, 12 respondents will each Metastasis-Free Survival Endpoint in
of submissions received from spend 1 hour reading the guidance Clinical Trials; Draft Guidance for
manufacturers of such products, TTB document, for a total of 12 hours. Thus, Industry; Availability
estimates the annual number of we estimate the total hour burden of the
respondents to be 12 and the annual AGENCY: Food and Drug Administration,
proposed collection of information to be HHS.
number of disclosures to be 24. Thus,
186 hours (174 hours + 12 hours = 186 ACTION: Notice of availability.
we adopt TTB’s estimate of 12 annual
respondents, and an annual number of hours).
SUMMARY: The Food and Drug
disclosures per respondent of 2 in table The guidance also refers to previously Administration (FDA or Agency) is
1. approved collections of information announcing the availability of a draft
Our estimates of the average burden found in our regulations. The guidance for industry entitled
per disclosure for each collection collections of information in §§ 101.3, ‘‘Nonmetastatic, Castration-Resistant
provision are based on our experience 101.4, 101.5, 101.9, 101.22, and 101.105 Prostate Cancer: Considerations for
with food labeling under the Agency’s have been approved under OMB control Metastasis-Free Survival Endpoint in
jurisdiction. The estimated average number 0910–0381. Allergen labeling of Clinical Trials.’’ This draft guidance
burden per disclosure for §§ 101.3, these beers under section 403(w)(1) of provides recommendations to sponsors
101.4, 101.5, 101.9, 101.22, and 101.105 the FD&C Act, which was added by the regarding the use of metastasis-free
in table 1 are equal to, and based upon, Food Allergen Labeling and Consumer survival (MFS) as an endpoint in
the estimated average burden per Protection Act of 2004, has been clinical trials for nonmetastatic,
disclosure approved by OMB in OMB approved under OMB control number castration-resistant prostate cancer
control number 0910–0381. We further 0910–0792. (nmCRPC) development programs for
estimate that the labeling burden of drug or biological products regulated by
Dated: November 7, 2018.
section 403(w)(1) of the FD&C Act, the Center for Drug Evaluation and
which specifies requirements for the Leslie Kux, Research (CDER) and the Center for
declaration of food allergens, will be 1 Associate Commissioner for Policy. Biologics Evaluation and Research
hour based upon the similarity of the [FR Doc. 2018–24786 Filed 11–13–18; 8:45 am] (CBER).
requirements to that of § 101.4. Finally, BILLING CODE 4164–01–P DATES: Submit either electronic or
FDA estimates that a respondent will written comments on the draft guidance
spend 1 hour reading the guidance. by January 14, 2019 to ensure that the
Thus, we estimate that 12 respondents Agency considers your comment on this
will each label 2 products annually, for draft guidance before it begins work on
a total of 24 labels. We estimate that the the final version of the guidance.
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![Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices 56859
Dated: November 7, 2018. made by the Social Security and guidelines of general applicability
Leslie Kux, Administration (SSA). not issued as regulations at least every
Associate Commissioner for Policy. The Medicare claim, organization three months in the Federal Register.
[FR Doc. 2018–24763 Filed 11–13–18; 8:45 am] determination, coverage determination,
and at-risk determination appeals II. Format for the Quarterly Issuance
BILLING CODE 4164–01–P
processes consist of four levels of Notices
administrative review, and a fifth level This quarterly notice provides the
DEPARTMENT OF HEALTH AND of review with the Federal district specific updates to the OCPM that have
HUMAN SERVICES courts after administrative remedies occurred in the three-month period of
under HHS regulations have been July through September 2018. A
[OMHA–1802–N] exhausted. The first two levels of review hyperlink to the available chapters on
are administered by the Centers for the OMHA website is provided below.
Medicare Program; Administrative Law Medicare & Medicaid Services (CMS) The OMHA website contains the most
Judge Hearing Program for Medicare and conducted by Medicare contractors current, up-to-date chapters and
Claim and Entitlement Appeals; for claim appeals, by MAOs and an revisions to chapters, and will be
Quarterly Listing of Program independent review entity for Part C available earlier than we publish our
Issuances—July Through September organization determination appeals, or quarterly notice. We believe the OMHA
2018 by PDPSs and an independent review website provides more timely access to
AGENCY: Office of Medicare Hearings entity for Part D coverage determination the current OCPM chapters for those
and Appeals (OMHA), HHS. and at-risk determination appeals. The involved in the Medicare claim;
ACTION: Notice. third level of review is administered by organization, coverage, and at-risk
OMHA and conducted by determination; and entitlement appeals
SUMMARY: This quarterly notice lists the Administrative Law Judges and attorney processes. We also believe the website
OMHA Case Processing Manual (OCPM) adjudicators. The fourth level of review offers the public a more convenient tool
instructions that were published from is administered by the HHS for real time access to current OCPM
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staff direction for processing appeals at late enrollment penalty, and IRMAA OMHA website proves to be difficult,
the OMHA level of adjudication. reconsiderations made by SSA; a fourth the contact person listed above can
FOR FURTHER INFORMATION CONTACT: level of review with the Federal district provide the information.
Jason Green, by telephone at (571) 777– courts is available after administrative
remedies within SSA and HHS have III. How To Use the Notice
2723, or by email at jason.green@
hhs.gov. been exhausted. This notice lists the OCPM chapters
Sections 1869, 1155, 1876(c)(5)(B), and subjects published during the
SUPPLEMENTARY INFORMATION: 1852(g)(5), and 1860D–4(h) of the Act quarter covered by the notice so the
I. Background are implemented through the reader may determine whether any are
regulations at 42 CFR part 405 subparts of particular interest. We expect this
The Office of Medicare Hearings and I and J; part 417, subpart Q; part 422, notice to be used in concert with future
Appeals (OMHA), a staff division within subpart M; part 423, subparts M and U; published notices. The OCPM can be
the Office of the Secretary within the and part 478, subpart B. As noted above, accessed at https://www.hhs.gov/about/
U.S. Department of Health and Human OMHA administers the nationwide agencies/omha/the-appeals-process/
Services (HHS), administers the Administrative Law Judge hearing case-processing-manual/index.html.
nationwide Administrative Law Judge program in accordance with these
hearing program for Medicare claim; statutes and applicable regulations. To IV. OCPM Releases for July Through
organization, coverage, and at-risk help ensure nationwide consistency in September 2018
determination; and entitlement appeals that effort, OMHA established a manual, The OCPM is used by OMHA
under sections 1869, 1155, the OCPM. Through the OCPM, the adjudicators and staff to administer the
1876(c)(5)(B), 1852(g)(5), and 1860D– OMHA Chief Administrative Law Judge OMHA program. It offers day-to-day
4(h) of the Social Security Act (the Act). establishes the day-to-day procedures operating instructions, policies, and
OMHA ensures that Medicare for carrying out adjudicative functions, procedures based on statutes and
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Medicare Advantage organizations appeals at the OMHA level of the three-month period of July through
(MAOs), Medicaid State agencies, and adjudication for Medicare Part A and B September 2018. This information is
applicable plans, have a fair and claims; Part C organization available on our website at https://
impartial forum to address determinations; Part D coverage www.hhs.gov/about/agencies/omha/the-
disagreements with Medicare coverage determinations and at-risk appeals-process/case-processing-
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Medicare contractors, MAOs, or Part D entitlement, Part B late enrollment
plan sponsors (PDPSs), and penalty, and IRMAA determinations. OCPM Chapter 5: Representatives
determinations related to Medicare Section 1871(c) of the Act requires Chapter 5, Representatives. This
eligibility and entitlement, Part B late that the Secretary publish a list of all chapter describes the role of
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monthly adjustment amounts (IRMAA) interpretive rules, statements of policy, including the documentation required
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Document Created: 2018-11-14 03:32:18
Document Modified: 2018-11-14 03:32:18
| 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. | |
| Dates | Submit either electronic or written comments on the draft guidance by January 14, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240- 402-0489; 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 56857 |
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