82 FR 26488 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 108 (June 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 108 (June 7, 2017)
| Page Range | 26488-26489 | |
| FR Document | 2017-11819 |
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)] [Notices] [Pages 26488-26489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11819] [[Page 26488]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2732] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this meeting. DATES: The public meeting will be held on July 13, 2017, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions, including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-2732. The docket will close on July 10, 2017. Submit either electronic or written comments on this public meeting by July 10, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 10, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 10, 2017. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before June 26, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2017-N-2732 for ``Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. [[Page 26489]] SUPPLEMENTARY INFORMATION: Agenda: During the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche's AVASTIN (bevacizumab), submitted by Amgen Inc. The proposed indications/uses for this product are: (1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5- fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215- containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. During the afternoon session, the committee will discuss BLA 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.'s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. The proposed indications/uses for this product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multimodality anthracycline based therapy; (2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2- overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.\1\ --------------------------------------------------------------------------- \1\ This indication is protected by orphan drug exclusivity expiring on October 20, 2017. See the Orphan Drug Designations and Approvals database at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm. --------------------------------------------------------------------------- FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the docket (see the ADDRESSES section) on or before June 26, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:15 a.m., and 3:45 p.m. to 4:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 16, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 19, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Jay R. Fajiculay at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11819 Filed 6-6-17; 8:45 am] BILLING CODE 4164-01-P
![26488 Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
DEPARTMENT OF HEALTH AND Electronic Submissions submission. You should submit two
HUMAN SERVICES Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
Food and Drug Administration with a heading or cover note that states
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2017–N–2732] instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically, Agency will review this copy, including
Oncologic Drugs Advisory Committee; including attachments, to https:// the claimed confidential information, in
Notice of Meeting; Establishment of a www.regulations.gov will be posted to its consideration of comments. The
Public Docket; Request for Comments the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
AGENCY: Food and Drug Administration, redacted/blacked out, will be available
HHS. solely responsible for ensuring that your
comment does not include any for public viewing and posted on
ACTION: Notice; establishment of a confidential information that you or a https://www.regulations.gov. Submit
public docket; request for comments. third party may not wish to be posted, both copies to the Division of Dockets
such as medical information, your or Management. If you do not wish your
SUMMARY: The Food and Drug anyone else’s Social Security number, or name and contact information to be
Administration (FDA or Agency) confidential business information, such made publicly available, you can
announces a forthcoming public as a manufacturing process. Please note provide this information on the cover
advisory committee meeting of the that if you include your name, contact sheet and not in the body of your
Oncologic Drugs Advisory Committee. information, or other information that comments and you must identify this
The general function of the committee is identifies you in the body of your information as ‘‘confidential.’’ Any
to provide advice and recommendations comments, that information will be information marked as ‘‘confidential’’
to the Agency on FDA’s regulatory posted on https://www.regulations.gov. will not be disclosed except in
issues. The meeting will be open to the • If you want to submit a comment accordance with 21 CFR 10.20 and other
public. FDA is establishing a docket for with confidential information that you applicable disclosure law. For more
public comment on this meeting. do not wish to be made available to the information about FDA’s posting of
DATES: The public meeting will be held public, submit the comment as a comments to public dockets, see 80 FR
on July 13, 2017, from 8 a.m. to 5 p.m. written/paper submission and in the 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/
ADDRESSES: FDA White Oak Campus, fdsys/pkg/FR-2015-09-18/pdf/2015-
10903 New Hampshire Ave., Bldg. 31 Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Conference Center, the Great Room (Rm. Written/Paper Submissions Docket: For access to the docket to
1503), Silver Spring, MD 20993–0002. read background documents or the
Submit written/paper submissions as
Answers to commonly asked questions, electronic and written/paper comments
follows:
including information regarding special
• Mail/Hand delivery/Courier (for received, go to https://
accommodations due to a disability, www.regulations.gov and insert the
written/paper submissions): Division of
visitor parking, and transportation may docket number, found in brackets in the
Dockets Management (HFA–305), Food
be accessed at: https://www.fda.gov/ heading of this document, into the
and Drug Administration, 5630 Fishers
AdvisoryCommittees/ ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
AboutAdvisoryCommittees/
• For written/paper comments and/or go to the Division of Dockets
ucm408555.htm. Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets
FDA is establishing a docket for Management, FDA will post your 1061, Rockville, MD 20852.
public comment on this meeting. The comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: Jay
docket number is FDA–2017–N–2732. except for information submitted, R. Fajiculay, Center for Drug Evaluation
The docket will close on July 10, 2017. marked and identified, as confidential, and Research, Food and Drug
Submit either electronic or written if submitted as detailed in Administration, 10903 New Hampshire
comments on this public meeting by ‘‘Instructions.’’ Ave., Bldg. 31, Rm. 2417, Silver Spring,
July 10, 2017. Late, untimely filed Instructions: All submissions received MD 20993–0002, 301–796–9001, FAX:
comments will not be considered. must include the Docket No. FDA– 301–847–8533, email: ODAC@
Electronic comments must be submitted 2017–N–2732 for ‘‘Oncologic Drugs fda.hhs.gov, or FDA Advisory
on or before July 10, 2017. The https:// Advisory Committee; Notice of Meeting; Committee Information Line, 1–800–
www.regulations.gov electronic filing Establishment of a Public Docket; 741–8138 (301–443–0572 in the
system will accept comments until Request for Comments.’’ Received Washington, DC area). A notice in the
midnight Eastern Time at the end of July comments, those filed in a timely Federal Register about last minute
10, 2017. Comments received by mail/ manner (see ADDRESSES), will be placed modifications that impact a previously
hand delivery/courier (for written/paper in the docket and, except for those announced advisory committee meeting
submissions) will be considered timely submitted as ‘‘Confidential cannot always be published quickly
if they are postmarked or the delivery Submissions,’’ publicly viewable at enough to provide timely notice.
service acceptance receipt is on or https://www.regulations.gov or at the Therefore, you should always check the
before that date. Division of Dockets Management Agency’s Web site at https://
sradovich on DSK3GMQ082PROD with NOTICES
Comments received on or before June between 9 a.m. and 4 p.m., Monday www.fda.gov/AdvisoryCommittees/
26, 2017, will be provided to the through Friday. default.htm and scroll down to the
committee. Comments received after • Confidential Submissions—To appropriate advisory committee meeting
that date will be taken into submit a comment with confidential link, or call the advisory committee
consideration by the Agency. information that you do not wish to be information line to learn about possible
You may submit comments as made publicly available, submit your modifications before coming to the
follows: comments only as a written/paper meeting.
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![Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices 26489
SUPPLEMENTARY INFORMATION: FDA intends to make background ucm111462.htm for procedures on
Agenda: During the morning session, material available to the public no later public conduct during advisory
the committee will discuss biologics than 2 business days before the meeting. committee meetings.
license application (BLA) 761028 for If FDA is unable to post the background Notice of this meeting is given under
ABP 215, a proposed biosimilar to material on its Web site prior to the the Federal Advisory Committee Act (5
Genentech/Roche’s AVASTIN meeting, the background material will U.S.C. app. 2).
(bevacizumab), submitted by Amgen be made publicly available at the
Inc. The proposed indications/uses for Dated: June 1, 2017.
location of the advisory committee
this product are: (1) For the first- or meeting, and the background material Anna K. Abram,
second-line treatment of patients with will be posted on FDA’s Web site after Deputy Commissioner for Policy, Planning,
metastatic carcinoma of the colon or the meeting. Background material is Legislation, and Analysis.
rectum in combination with intravenous available at https://www.fda.gov/ [FR Doc. 2017–11819 Filed 6–6–17; 8:45 am]
5-fluorouracil-based chemotherapy; (2) AdvisoryCommittees/Calendar/ BILLING CODE 4164–01–P
in combination with fluoropyrimidine- default.htm. Scroll down to the
irinotecan- or fluoropyrimidine- appropriate advisory committee meeting
oxaliplatin-based chemotherapy, for the link. DEPARTMENT OF HEALTH AND
second-line treatment of patients with Procedure: Interested persons may HUMAN SERVICES
metastatic colorectal cancer who have present data, information, or views,
progressed on a first-line ABP 215- Food and Drug Administration
orally or in writing, on issues pending
containing regimen; (3) for the first-line before the committee. All electronic and
treatment of unresectable, locally written submissions submitted to the [Docket No. FDA–2009–N–0501]
advanced, recurrent or metastatic non- docket (see the ADDRESSES section) on or
squamous, non-small cell lung cancer in before June 26, 2017, will be provided Agency Information Collection
combination with carboplatin and to the committee. Oral presentations Activities; Proposed Collection;
paclitaxel; (4) for the treatment of from the public will be scheduled Comment Request; Third Party
glioblastoma with progressive disease in between approximately 10:45 a.m. to Disclosure and Recordkeeping
adult patients following prior therapy as 11:15 a.m., and 3:45 p.m. to 4:15 p.m. Requirements for Reportable Food
a single agent; (5) for the treatment of Those individuals interested in making
metastatic renal cell carcinoma in AGENCY: Food and Drug Administration,
formal oral presentations should notify HHS.
combination with interferon alfa; and the contact person and submit a brief
(6) in combination with paclitaxel and statement of the general nature of the ACTION: Notice.
cisplatin or paclitaxel and topotecan for evidence or arguments they wish to
the treatment of persistent, recurrent, or present, the names and addresses of SUMMARY: The Food and Drug
metastatic carcinoma of the cervix. proposed participants, and an Administration (FDA or we) is
During the afternoon session, the indication of the approximate time announcing an opportunity for public
committee will discuss BLA 761074 for requested to make their presentation on comment on the proposed collection of
MYL–1401O, a proposed biosimilar to or before June 16, 2017. Time allotted certain information by the Agency.
Genentech Inc.’s HERCEPTIN for each presentation may be limited. If Under the Paperwork Reduction Act of
(trastuzumab), submitted by Mylan the number of registrants requesting to 1995 (PRA), Federal Agencies are
GmbH. The proposed indications/uses speak is greater than can be reasonably required to publish notice in the
for this product are: (1) For adjuvant accommodated during the scheduled Federal Register concerning each
treatment of HER2 overexpressing node open public hearing session, FDA may proposed collection of information,
positive or node negative (ER/PR conduct a lottery to determine the including each proposed extension of an
negative or with one high risk feature) speakers for the scheduled open public existing collection of information, and
breast cancer; (a) as part of a treatment hearing session. The contact person will to allow 60 days for public comment in
regimen consisting of doxorubicin, notify interested persons regarding their response to the notice. This notice
cyclophosphamide, and either request to speak by June 19, 2017. solicits comments on the information
paclitaxel or docetaxel; (b) with Persons attending FDA’s advisory collection provisions of FDA’s third
docetaxel and carboplatin; or (c) as a committee meetings are advised that the party disclosure and recordkeeping
single agent following multimodality Agency is not responsible for providing requirements for reportable food.
anthracycline based therapy; (2) in access to electrical outlets. DATES: Submit either electronic or
combination with paclitaxel for first- FDA welcomes the attendance of the written comments on the collection of
line treatment of HER2-overexpressing public at its advisory committee information by August 7, 2017.
metastatic breast cancer; (3) as a single meetings and will make every effort to
agent for treatment of HER2- ADDRESSES: You may submit comments
accommodate persons with disabilities.
overexpressing breast cancer in patients as follows. Please note that late,
If you require special accommodations
who have received one or more untimely filed comments will not be
due to a disability, please contact Jay R.
chemotherapy regimens for metastatic considered. Electronic comments must
Fajiculay at least 7 days in advance of
disease; and (4) in combination with be submitted on or before August 7,
the meeting.
cisplatin and capecitabine or 5- FDA is committed to the orderly 2017. The https://www.regulations.gov
fluorouracil, for the treatment of conduct of its advisory committee electronic filing system will accept
comments until midnight Eastern Time
sradovich on DSK3GMQ082PROD with NOTICES
patients with HER2 overexpressing meetings. Please visit our Web site at
metastatic gastric or gastroesophageal https://www.fda.gov/ at the end of August 7, 2017. Comments
junction adenocarcinoma who have not AdvisoryCommittees/ received by mail/hand delivery/courier
received prior treatment for metastatic AboutAdvisoryCommittees/ (for written/paper submissions) will be
disease.1 considered timely if they are
Orphan Drug Designations and Approvals database
postmarked or the delivery service
1 Thisindication is protected by orphan drug at http://www.accessdata.fda.gov/scripts/ acceptance receipt is on or before that
exclusivity expiring on October 20, 2017. See the opdlisting/oopd/index.cfm. date.
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Document Created: 2017-06-07 02:00:39
Document Modified: 2017-06-07 02:00:39
| 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; establishment of a public docket; request for comments. | |
| Dates | The public meeting will be held on July 13, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 26488 |
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