81 FR 13373 - Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability and Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 49 (March 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 49 (March 14, 2016)
| Page Range | 13373-13375 | |
| FR Document | 2016-05626 |
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)] [Notices] [Pages 13373-13375] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05626] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4750] Implementation of the ``Deemed To Be a License'' Provision of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Implementation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance describes FDA's approach to implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) on or before March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this draft guidance describes FDA's interpretation of the ``deemed to be a license'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that have been or will be approved under the FD&C Act on or before March 23, 2020. This draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation the transition provisions of the BPCI Act. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 13, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2015-D-4750 for ``Implementation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability and Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 [[Page 13374]] 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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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. 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 to 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: Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301- 796-3601; 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 ``Implementation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance describes FDA's approach to implementation of the provision of the BPCI Act under which an application for a biological product approved under section 505 of the FD&C Act (21 U.S.C. 355) on or before March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020. Specifically, this draft guidance describes FDA's interpretation of the ``deemed to be a license'' provision in section 7002(e) of the BPCI Act for biological products that have been or will be approved under section 505 of the FD&C Act on or before March 23, 2020. This draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under section 505 of the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of section 7002(e) of the BPCI Act. Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act changed 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).'' FDA has interpreted the statutory terms ``protein'' and ``chemically synthesized polypeptide'' to implement the amended definition of ``biological product'' (see FDA's guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). The BPCI Act requires that a marketing application for a ``biological product'' 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)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, 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) of the BPCI Act). Among other things, because the BPCI Act provides only that an application that is approved on March 23, 2020, shall be deemed to be a license, FDA interprets section 7002(e) of the BPCI Act to mean that the Agency will not approve any application under section 505 of the FD&C Act for a biological product subject to the transition provisions that is pending or tentatively approved ``on'' March 23, 2020, even though section 7002(e)(2) of the BPCI Act expressly permits submission of an application under section 505 of the FD&C Act ``not later than'' March 23, 2020, if certain criteria are met. Such an application may, for example, be withdrawn and resubmitted under section 351(a) or 351(k) of the PHS Act, as appropriate. FDA recognizes that this interpretation could have a significant impact on development programs for any proposed protein products intended for submission under section 505 of the FD&C Act that are not able to receive final approval by March 23, 2020, and provides recommendations to sponsors in the draft guidance. We invite comment on the Agency's approach to implementation of the ``deemed to be a license'' provision of the BPCI Act, as described in the draft guidance. 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 implementation of the ``deemed to be a license'' provision of the BPCI Act. 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. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by [[Page 13375]] 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 0910-0014; the collection of information in 21 CFR part 314 has been approved under 0910-0001; the collection of information in 21 CFR part 601 has been approved under 0910-0338; and the collection of information for applications submitted under section 351(k) of the PHS Act has been approved under 0910-0719. In accordance with the PRA, before publication of the final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations or guidances. III. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Dated: March 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05626 Filed 3-11-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices 13373
material on its Web site prior to the Dated: March 8, 2016. ADDRESSES: You may submit comments
meeting, the background material will Jill Hartzler Warner, as follows:
be made publicly available at the Associate Commissioner for Special Medical
Electronic Submissions
location of the advisory committee Programs.
meeting, and the background material [FR Doc. 2016–05573 Filed 3–11–16; 8:45 am] Submit electronic comments in the
will be posted on FDA’s Web site after BILLING CODE 4164–01–P
following way:
the meeting. Background material is • Federal eRulemaking Portal: http://
available at http://www.fda.gov/ www.regulations.gov. Follow the
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND instructions for submitting comments.
default.htm. Scroll down to the HUMAN SERVICES Comments submitted electronically,
appropriate advisory committee meeting including attachments, to http://
link. Food and Drug Administration www.regulations.gov will be posted to
the docket unchanged. Because your
Procedure: Interested persons may [Docket No. FDA–2015–D–4750] comment will be made public, you are
present data, information, or views,
solely responsible for ensuring that your
orally or in writing, on issues pending Implementation of the ‘‘Deemed To Be comment does not include any
before the committees. All electronic a License’’ Provision of the Biologics confidential information that you or a
and written submissions submitted to Price Competition and Innovation Act third party may not wish to be posted,
the Docket (see the ADDRESSES section) of 2009; Draft Guidance for Industry; such as medical information, your or
on or before April 19, 2016, will be Availability and Request for Comments anyone else’s Social Security number, or
provided to the committees. Oral
AGENCY: Food and Drug Administration, confidential business information, such
presentations from the public will be
HHS. as a manufacturing process. Please note
scheduled between approximately 10:30
that if you include your name, contact
a.m. and 12:30 p.m. on May 4, 2016. ACTION:Notice of availability; request
information, or other information that
Those individuals interested in making for comments.
identifies you in the body of your
formal oral presentations should notify
SUMMARY: The Food and Drug comments, that information will be
the contact person and submit a brief
Administration (FDA or Agency) is posted on http://www.regulations.gov.
statement of the general nature of the • If you want to submit a comment
evidence or arguments they wish to announcing the availability of a draft
guidance for industry entitled with confidential information that you
present, the names and addresses of do not wish to be made available to the
proposed participants, and an ‘‘Implementation of the ‘Deemed to be a
License’ Provision of the Biologics Price public, submit the comment as a
indication of the approximate time written/paper submission and in the
requested to make their presentation on Competition and Innovation Act of
2009.’’ This draft guidance describes manner detailed (see ‘‘Written/Paper
or before April 11, 2016. Time allotted Submissions’’ and ‘‘Instructions’’).
for each presentation may be limited. If FDA’s approach to implementation of
the number of registrants requesting to the statutory provision under which an Written/Paper Submissions
speak is greater than can be reasonably application for a biological product
Submit written/paper submissions as
accommodated during the scheduled approved under the Federal Food, Drug,
follows:
open public hearing session, FDA may and Cosmetic Act (FD&C Act) on or • Mail/Hand delivery/Courier (for
conduct a lottery to determine the before March 23, 2020, will be deemed written/paper submissions): Division of
speakers for the scheduled open public to be a license for the biological product Dockets Management (HFA–305), Food
hearing session. The contact person will under the Public Health Service Act and Drug Administration, 5630 Fishers
notify interested persons regarding their (PHS Act) on March 23, 2020. Lane, Rm. 1061, Rockville, MD 20852.
request to speak by April 12, 2016. Specifically, this draft guidance • For written/paper comments
describes FDA’s interpretation of the submitted to the Division of Dockets
Persons attending FDA’s advisory
‘‘deemed to be a license’’ provision of Management, FDA will post your
committee meetings are advised that the
the Biologics Price Competition and comment, as well as any attachments,
Agency is not responsible for providing
Innovation Act of 2009 (BPCI Act) for except for information submitted,
access to electrical outlets.
biological products that have been or marked and identified, as confidential,
FDA welcomes the attendance of the will be approved under the FD&C Act
public at its advisory committee if submitted as detailed in
on or before March 23, 2020. This draft ‘‘Instructions.’’
meetings and will make every effort to guidance also provides Instructions: All submissions received
accommodate persons with disabilities. recommendations to sponsors of must include the Docket No. FDA–
If you require accommodations due to a proposed protein products intended for 2015–D–4750 for ‘‘Implementation of
disability, please contact Stephanie L. submission in an application that may the ‘Deemed to be a License’ Provision
Begansky at least 7 days in advance of not receive final approval under the of the Biologics Price Competition and
the meeting. FD&C Act on or before March 23, 2020, Innovation Act of 2009; Draft Guidance
FDA is committed to the orderly to facilitate alignment of product for Industry; Availability and Request
conduct of its advisory committee development plans with FDA’s for Comments.’’ Received comments
meetings. Please visit our Web site at interpretation the transition provisions will be placed in the docket and, except
http://www.fda.gov/ of the BPCI Act. for those submitted as ‘‘Confidential
AdvisoryCommittees/ DATES: Although you can comment on
jstallworth on DSK7TPTVN1PROD with NOTICES
Submissions,’’ publicly viewable at
AboutAdvisoryCommittees/ any guidance at any time (see 21 CFR http://www.regulations.gov or at the
ucm111462.htm for procedures on 10.115(g)(5)), to ensure that the Agency Division of Dockets Management
public conduct during advisory considers your comment on this draft between 9 a.m. and 4 p.m., Monday
committee meetings. guidance before it begins work on the through Friday.
Notice of this meeting is given under final version of the guidance, submit • Confidential Submissions—To
the Federal Advisory Committee Act (5 either electronic or written comments submit a comment with confidential
U.S.C. app. 2). on the draft guidance by May 13, 2016. information that you do not wish to be
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![Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices 13375
the Office of Management and Budget discussion with experts in the field must register online at: http://pediatric
(OMB) under the Paperwork Reduction examining the need and path forward safety.eventbrite.com before April 7,
Act of 1995 (44 U.S.C. 3501–3520). The for long-term pediatric safety studies. 2016. For those without Internet access,
collection of information in 21 CFR part Day 1 of the public workshop will focus please contact Renan A. Bonnel (see FOR
312 has been approved under 0910– on an exposition of the successes and FURTHER INFORMATION CONTACT) to
0014; the collection of information in 21 challenges of long-term safety studies in register. In the event that a minimum
CFR part 314 has been approved under children. Day 2 of the public workshop number of participants have not
0910–0001; the collection of will focus on suggestions for the future registered, the workshop will be
information in 21 CFR part 601 has been on study design and implementation of postponed. Registered participants will
approved under 0910–0338; and the long-term safety studies in children. be notified of any change. Onsite
collection of information for Viewpoints of patient representatives of registration will be available if seating
applications submitted under section children with chronic conditions and permits it. Registration information, the
351(k) of the PHS Act has been industry will be included. agenda, and additional background
approved under 0910–0719. In DATES: The public workshop will be materials can be found at http://www.
accordance with the PRA, before held on April 13 and 14, 2016, from 8 fda.gov/NewsEvents/Meetings
publication of the final guidance a.m. to 5 p.m. See the SUPPLEMENTARY ConferencesWorkshops/
document, FDA intends to solicit public INFORMATION section for registration date ucm477639.htm.
comment and obtain OMB approval for and information. If you need special accommodations
any information collections due to a disability, please contact Renan
ADDRESSES: The public workshop will
recommended in this guidance that are A. Bonnel (see FOR FURTHER INFORMATION
be held at The DoubleTree by Hilton
new or that would represent material CONTACT) at least 7 days in advance.
Hotel—Bethesda, 8120 Wisconsin Ave.,
modifications to previously approved Persons attending the meeting are
Bethesda, MD 20814.
collections of information found in FDA advised that FDA is not responsible for
FOR FURTHER INFORMATION CONTACT: providing access to electrical outlets.
regulations or guidances.
Renan A. Bonnel, Office of Pediatric Web cast: The live Web cast on April
III. Electronic Access Therapeutics, Food and Drug 13, 2016, will be available at: https://
Persons with access to the Internet Administration, 10903 New Hampshire event.webcasts.com/starthere.jsp
may obtain the document at http:// Ave., Silver Spring, MD 20993–0002, ?ei=1093258. After the morning session,
www.fda.gov/Drugs/Guidance 301–796–8654, FAX: 301–847–8640, users will be automatically redirected to
ComplianceRegulatoryInformation/ email: renan.bonnel@fda.hhs.gov. the afternoon link. Should you lose
Guidances/default.htm, http:// SUPPLEMENTARY INFORMATION: connection over lunch, please use the
www.fda.gov/BiologicsBloodVaccines/ following link for the afternoon session
I. Background
GuidanceComplianceRegulatory (note that it is different from the
Information/default.htm or http:// Medical product safety studies in morning’s session): https://event.
www.regulations.gov. children are usually performed for 6 webcasts.com/starthere.jsp?ei=1093259.
Dated: March 8, 2016.
months or less. In children, On April 14, 2016, the live Web cast
measurement of long-term outcomes is will be available at: https://event.
Leslie Kux,
particularly challenging since, webcasts.com/starthere.jsp?ei=1093263.
Associate Commissioner for Policy.
compared to adults, children are After the morning session, users will be
[FR Doc. 2016–05626 Filed 3–11–16; 8:45 am] undergoing dramatic growth and automatically redirected to the
BILLING CODE 4164–01–P developmental changes. This 2-day afternoon link. Should you lose
public workshop will focus on the connection over lunch, please use the
challenges of long-term follow-up in following link for the afternoon session
DEPARTMENT OF HEALTH AND children receiving medical products. (note that it is different from the
HUMAN SERVICES The first day of the public workshop morning’s session): https://event.
Food and Drug Administration will focus on the problems or barriers, webcasts.com/starthere.jsp?ei=1093265.
including; challenges with study design, The Web cast will only be for listening
[Docket No. FDA–2016–N–0001] data capture, infrastructure, and and there will not be an opportunity for
endpoints. Viewpoints of parents and Web cast participants to speak.
Advancing the Development of industry will be represented. The The videocast will be posted after the
Pediatric Therapeutics: Successes and second day of the public workshop will workshop at http://www.fda.gov/News
Challenges of Performing Long-Term include panel discussions to propose Events/MeetingsConferencesWorkshops/
Pediatric Safety Studies; Public solutions to the problems posed on day ucm477639.htm.
Workshop one and to discuss the epidemiological Transcripts: Transcripts of the
AGENCY: Food and Drug Administration, challenges posed by the collection of workshop will be available for review at
HHS. data on different types of adverse the Division of Dockets Management
ACTION: Notice of public workshop. events. On both days of the public (HFA–305), Food and Drug
workshop there will be a certain amount Administration, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug of time on the agenda for attendee 1061, Rockville, MD 20852, and at
Administration’s (FDA) Office of questions or comments. http://www.regulations.gov
Pediatric Therapeutics (OPT) and Center approximately 30 days after the
for Drug Evaluation and Research are II. Participation in the Public workshop. A transcript will also be
jstallworth on DSK7TPTVN1PROD with NOTICES
announcing a 2-day public workshop Workshop available in either hard copy or on CD–
entitled ‘‘Advancing the Development of Registration: There is no fee to attend ROM, after submission of a Freedom of
Pediatric Therapeutics (ADEPT): the public workshop, but attendees Information request. Send written
Successes and Challenges of Performing should register in advance. Space is requests to the Division of Freedom of
Long-Term Pediatric Safety Studies.’’ limited, and registration will be on a Information. The Freedom of
The purpose of this 2-day public first-come, first-served basis. Persons Information address is available on the
workshop is for FDA to have an open interested in attending this workshop Agency’s Web site at
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Document Created: 2016-03-12 01:00:02
Document Modified: 2016-03-12 01:00:02
| 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; request for comments. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 13, 2016. | |
| Contact | Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301- 796-3601; 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 | 81 FR 13373 |
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