81 FR 57919 - Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 164 (August 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 164 (August 24, 2016)
| Page Range | 57919-57921 | |
| FR Document | 2016-20221 |
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)] [Notices] [Pages 57919-57921] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20221] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1580] Patient Preference Information--Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; 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 the guidance entitled ``Patient Preference Information--Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI), which may inform FDA's benefit-risk determinations in the premarket review of premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, and de novo classification requests. This guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' originally issued on March 28, 2012, that has been edited to be consistent with this guidance document. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. 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-1580 for ``Patient Preference Information--Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' If you are making submissions that also address the edits to the Level 2 guidance, the submissions received must include the Docket No. FDA-2011-D-0577 for ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.'' Received comments will be placed in the docket(s) noted 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 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 [[Page 57920]] 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Patient Preference Information--Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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 request. FOR FURTHER INFORMATION CONTACT: Anindita Saha, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002, 301-796-2537, [email protected]; 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, 240-402- 7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled ``Patient Preference Information--Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' FDA believes that patients can and should bring their own experiences to bear in helping the Agency to evaluate the benefit-risk profiles of certain devices. This kind of input can be important to consider during FDA's decisionmaking for these devices. This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect PPI, which may inform FDA's benefit-risk determinations in the premarket review of PMAs, HDE applications, and de novo requests. This guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. The objectives of this guidance are: (1) To encourage submission of PPI, if available, by sponsors or other stakeholders to FDA and to aid in FDA decisionmaking; (2) to outline recommended qualities of patient preference studies, which may result in valid scientific evidence; (3) to provide recommendations for collecting and submitting PPI to FDA; and (4) to discuss FDA's inclusion of PPI in its decision summaries and provide recommendations for the inclusion of such information in device labeling, where appropriate. The guidance also includes hypothetical examples that illustrate how PPI may inform FDA's decisionmaking. The guidance applies to both diagnostic and therapeutic devices that are subject to these review processes. Additionally, this guidance may be information to other stakeholders such as patient groups and academia who may wish to conduct patient preference studies. In the Federal Register of May 18, 2015 (80 FR 28277), FDA announced the availability of the draft of this guidance and interested persons were invited to comment by August 17, 2015. FDA has considered all of the public comments received in finalizing this guidance. FDA is also issuing a Level 2 update to the guidance document entitled ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' which was originally issued on March 28, 2012, to ensure consistency with the terminology and concepts presented in this guidance. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Patient Preference Information--Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' 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. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Patient Preference Information-- Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling'' or ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500006 or 1772 respectively to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to currently 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 collections of information in 21 CFR 812.25(c) have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910- 0120; the collections of information in 21 CFR part 814, subparts B and E have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; the collections of information in 21 CFR part 822 have been approved under OMB control number 0910-0449; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; and the collections of information in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. [[Page 57921]] Dated: August 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20221 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57919
presentation or to support a (HDE) applications, and de novo except for information submitted,
presentation, are subject to inspection. classification requests. This guidance marked and identified, as confidential,
We cannot assume responsibility for also discusses FDA’s inclusion of PPI in if submitted as detailed in
coordinating the receipt, transfer, its decision summaries and provides ‘‘Instructions.’’
transport, storage, set up, safety, or recommendations for the inclusion of Instructions: All submissions received
timely arrival of any personal such information in device labeling for must include the Docket No. FDA–
belongings or items used for certain devices. FDA is also issuing a 2015–D–1580 for ‘‘Patient Preference
presentation or to support a Level 2 updated version of the guidance Information—Voluntary Submission,
presentation. document entitled ‘‘Factors To Consider Review in PMAs, HDE Applications,
When Making Benefit-Risk and De Novo Requests, and Inclusion in
Note: Individuals who are not registered in
advance will not be permitted to enter the Determinations in Medical Device Decision Summaries and Device
building and will be unable to attend the Premarket Approval and De Novo Labeling.’’ If you are making
meeting. The public may not enter the Classifications,’’ originally issued on submissions that also address the edits
building earlier than 45 minutes prior to the March 28, 2012, that has been edited to to the Level 2 guidance, the submissions
convening of the meeting. be consistent with this guidance received must include the Docket No.
All visitors must be escorted in areas document. FDA–2011–D–0577 for ‘‘Factors To
other than the lower and first floor Consider When Making Benefit-Risk
DATES: Submit either electronic or Determinations in Medical Device
levels in the Central Building. written comments on this guidance at Premarket Approval and De Novo
Authority: Sec. 222 of the Public Health any time. General comments on Agency Classifications.’’ Received comments
Service Act (42 U.S.C. 217a) and sec. 10(a) guidance documents are welcome at any will be placed in the docket(s) noted
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) time. and, except for those submitted as
and 41 CFR 102–3). ADDRESSES: You may submit comments ‘‘Confidential Submissions,’’ publicly
Dated: August 16, 2016. as follows: viewable at http://www.regulations.gov
Andrew M. Slavitt, or at the Division of Dockets
Electronic Submissions
Acting Administrator, Centers for Medicare Management between 9 a.m. and 4 p.m.,
& Medicaid Services. Submit electronic comments in the Monday through Friday.
[FR Doc. 2016–20187 Filed 8–23–16; 8:45 am] following way: • Confidential Submissions—To
BILLING CODE 4120–01–P
• Federal eRulemaking Portal: http:// submit a comment with confidential
www.regulations.gov. Follow the information that you do not wish to be
instructions for submitting comments. made publicly available, submit your
DEPARTMENT OF HEALTH AND Comments submitted electronically, comments only as a written/paper
HUMAN SERVICES including attachments, to http:// submission. You should submit two
www.regulations.gov will be posted to copies total. One copy will include the
Food and Drug Administration the docket unchanged. Because your information you claim to be confidential
comment will be made public, you are with a heading or cover note that states
[Docket No. FDA–2015–D–1580]
solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS
Patient Preference Information— comment does not include any CONFIDENTIAL INFORMATION.’’ The
Voluntary Submission, Review in confidential information that you or a Agency will review this copy, including
Premarket Approval Applications, third party may not wish to be posted, the claimed confidential information, in
Humanitarian Device Exemption such as medical information, your or its consideration of comments. The
Applications, and De Novo Requests, anyone else’s Social Security number, or second copy, which will have the
and Inclusion in Decision Summaries confidential business information, such claimed confidential information
and Device Labeling; Guidance for as a manufacturing process. Please note redacted/blacked out, will be available
Industry, Food and Drug that if you include your name, contact for public viewing and posted on http://
Administration Staff and Other information, or other information that www.regulations.gov. Submit both
Stakeholders; Availability identifies you in the body of your copies to the Division of Dockets
comments, that information will be Management. If you do not wish your
AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. name and contact information to be
HHS. • If you want to submit a comment made publicly available, you can
ACTION: Notice of availability. with confidential information that you provide this information on the cover
do not wish to be made available to the sheet and not in the body of your
SUMMARY: The Food and Drug public, submit the comment as a comments and you must identify this
Administration (FDA or Agency) is written/paper submission and in the information as ‘‘confidential.’’ Any
announcing the availability of the manner detailed (see ‘‘Written/Paper information marked as ‘‘confidential’’
guidance entitled ‘‘Patient Preference Submissions’’ and ‘‘Instructions’’). will not be disclosed except in
Information—Voluntary Submission, accordance with 21 CFR 10.20 and other
Review in PMAs, HDE Applications, Written/Paper Submissions applicable disclosure law. For more
and De Novo Requests, and Inclusion in Submit written/paper submissions as information about FDA’s posting of
Decision Summaries and Device follows: comments to public dockets, see 80 FR
Labeling.’’ This document explains the • Mail/Hand delivery/Courier (for 56469, September 18, 2015, or access
principal concepts that sponsors and written/paper submissions): Division of the information at: http://www.fda.gov/
mstockstill on DSK3G9T082PROD with NOTICES
other stakeholders should consider Dockets Management (HFA–305), Food regulatoryinformation/dockets/
when choosing to collect patient and Drug Administration, 5630 Fishers default.htm.
preference information (PPI), which Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
may inform FDA’s benefit-risk • For written/paper comments read background documents or the
determinations in the premarket review submitted to the Division of Dockets electronic and written/paper comments
of premarket approval applications Management, FDA will post your received, go to http://
(PMAs), humanitarian device exemption comment, as well as any attachments, www.regulations.gov and insert the
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![Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57921
Dated: August 2, 2016. • If you want to submit a comment the information at: http://www.fda.gov/
Leslie Kux, with confidential information that you regulatoryinformation/dockets/
Associate Commissioner for Policy. do not wish to be made available to the default.htm.
[FR Doc. 2016–20221 Filed 8–23–16; 8:45 am] public, submit the comment as a Docket: For access to the docket to
BILLING CODE 4164–01–P
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to http://
DEPARTMENT OF HEALTH AND www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
HUMAN SERVICES
Submit written/paper submissions as heading of this document, into the
Food and Drug Administration follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for and/or go to the Division of Dockets
[Docket No. FDA–2007–D–0369] written/paper submissions): Division of Management, 5630 Fishers Lane, Rm.
Dockets Management (HFA–305), Food 1061, Rockville, MD 20852.
Bioequivalence Recommendations for and Drug Administration, 5630 Fishers Submit written requests for single
Fidaxomicin; Draft Guidance for Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the
Industry; Availability • For written/paper comments Division of Drug Information, Center for
AGENCY: Food and Drug Administration, submitted to the Division of Dockets Drug Evaluation and Research, Food
HHS. Management, FDA will post your and Drug Administration, 10001 New
ACTION: Notice of availability. comment, as well as any attachments, Hampshire Ave., Hillandale Building,
except for information submitted, 4th Floor, Silver Spring, MD 20993–
SUMMARY: The Food and Drug marked and identified, as confidential, 0002. Send one self-addressed adhesive
Administration (FDA) is announcing the if submitted as detailed in label to assist that office in processing
availability of a draft guidance for ‘‘Instructions.’’ your requests. See the SUPPLEMENTARY
industry on generic fidaxomicin tablets Instructions: All submissions received INFORMATION section for electronic
entitled ‘‘Draft Guidance on must include the Docket No. FDA– access to the draft guidance document.
Fidaxomicin.’’ The recommendations 2007–D–0369 for ‘‘Draft Guidance on FOR FURTHER INFORMATION CONTACT:
provide specific guidance on the design Fidaxomicin.’’ Received comments will Xiaoqiu Tang, Center for Drug
of bioequivalence (BE) studies to be placed in the docket and, except for Evaluation and Research (HFD–600),
support abbreviated new drug those submitted as ‘‘Confidential Food and Drug Administration, 10903
applications (ANDAs) for fidaxomicin Submissions,’’ will be publicly viewable New Hampshire Ave., Bldg. 75, Rm.
tablets. at http://www.regulations.gov or at the 4730, Silver Spring, MD 20993–0002,
Division of Dockets Management 301–796–5850.
DATES: Although you can comment on between 9 a.m. and 4 p.m., Monday
any guidance at any time (see 21 CFR SUPPLEMENTARY INFORMATION:
through Friday.
10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To I. Background
considers your comment on this draft submit a comment with confidential
guidance before it begins work on the In the Federal Register of June 11,
information that you do not wish to be 2010 (75 FR 33311), FDA announced the
final version of the guidance, submit made publicly available, submit your
either electronic or written comments availability of a guidance for industry
comments only as a written/paper entitled ‘‘Bioequivalence
on the draft guidance by October 24, submission. You should submit two
2016. Recommendations for Specific
copies total. One copy will include the Products,’’ which explained the process
ADDRESSES: You may submit comments information you claim to be confidential that would be used to make product-
as follows: with a heading or cover note that states specific BE recommendations available
‘‘THIS DOCUMENT CONTAINS to the public on FDA’s Web site at
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The http://www.fda.gov/Drugs/Guidance
Submit electronic comments in the Agency will review this copy, including ComplianceRegulatoryInformation/
following way: the claimed confidential information, in Guidances/default.htm.
• Federal eRulemaking Portal: http:// its consideration of comments. The As described in that guidance, FDA
www.regulations.gov. Follow the second copy, which will have the adopted this process to develop and
instructions for submitting comments. claimed confidential information disseminate product-specific BE
Comments submitted electronically, redacted/blacked out, will be available recommendations and to provide a
including attachments, to http:// for public viewing and posted on http:// meaningful opportunity for the public to
www.regulations.gov will be posted to www.regulations.gov. Submit both consider and comment on those
the docket unchanged. Because your copies to the Division of Dockets recommendations. This notice
comment will be made public, you are Management. If you do not wish your announces the availability of draft BE
solely responsible for ensuring that your name and contact information to be recommendations for generic
comment does not include any made publicly available, you can fidaxomicin tablets.
confidential information that you or a provide this information on the cover FDA initially approved new drug
third party may not wish to be posted, sheet and not in the body of your application (NDA) 201699 for DIFICID
such as medical information, your or comments and you must identify this (fidaxomicin) in May 2011. Currently,
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any there are no approved ANDAs for this
mstockstill on DSK3G9T082PROD with NOTICES
confidential business information, such information marked as ‘‘confidential’’ product. We are now issuing a draft
as a manufacturing process. Please note will not be disclosed except in guidance for industry on BE
that if you include your name, contact accordance with 21 CFR 10.20 and other recommendations for generic
information, or other information that applicable disclosure law. For more fidaxomicin tablets (‘‘Draft Guidance on
identifies you in the body of your information about FDA’s posting of Fidaxomicin’’).
comments, that information will be comments to public dockets, see 80 FR On May 6, 2015, Cubist
posted on http://www.regulations.gov. 56469, September 18, 2015, or access Pharmaceuticals, Inc. submitted a
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Document Created: 2016-08-24 03:02:22
Document Modified: 2016-08-24 03:02:22
| 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 this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Anindita Saha, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002, 301-796-2537, [email protected]; 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, 240-402- 7911. | |
| FR Citation | 81 FR 57919 |
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