83 FR 23464 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 98 (May 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 98 (May 21, 2018)
| Page Range | 23464-23466 | |
| FR Document | 2018-10723 |
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)] [Notices] [Pages 23464-23466] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10723] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0821] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the investigation of consumer perceptions of expressed modified risk claims. DATES: Submit either electronic or written comments on the collection of information by July 20, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 20, 2018. 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. 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-N-0821 for ``Investigation of Consumer Perceptions of Expressed Modified Risk Claims.'' 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 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 [[Page 23465]] 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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Investigation of Consumer Perceptions of Expressed Modified Risk Claims OMB Control Number 0910--NEW FDA's Center for Tobacco Products proposes to conduct a study to develop generalizable scientific knowledge to help inform its implementation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating information submitted to the Agency about how consumers understand and perceive modified risk tobacco products (MRTPs). Section 911 of the FD&C Act authorizes FDA to grant orders to persons to allow the marketing of MRTPs. The term ``modified risk tobacco product'' means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue a risk modification order under section 911(g)(1) of the FD&C Act authorizing the marketing of a MRTP only if the Agency determines that the product, as it is used by consumers, will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(1) of the FD&C Act). Alternatively, with respect to tobacco products that may not be commercially marketed under section 911(g)(1) of the FD&C Act, FDA may issue an exposure modification order under section 911(g)(2) of the FD&C Act authorizing the marketing of a MRTP if, the Agency determines that the standard in section 911(g)(2) of the FD&C Act is met, including, among other requirements, that: Any aspect of the label, labeling, or advertising that would cause the product to be an MRTP is limited to an explicit or implicit representation that the tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke; the order would be appropriate to promote the public health; the issuance of the order is expected to benefit the population as a whole taking into account both users and nonusers of tobacco products; and the existing evidence demonstrates that a measurable and substantial reduction in morbidity and mortality among individual tobacco users is reasonably likely to be shown in subsequent studies (section 911(g)(2) of the FD&C Act). In addition, section 911 of the FD&C Act requires that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all the diseases and health-related conditions associated with the use of tobacco products (section 911(h)(1) of the FD&C Act). The proposed research will inform the Agency's efforts to implement the provisions of the FD&C Act related to MRTPs. FDA proposes conducting a study to assist in determining appropriate methods for gathering information about how consumers perceive and understand modified risk information. The study would develop and validate measures of consumer perceptions of health risk from using tobacco products. Moreover, the study would test how participants' responses on these measures are affected by viewing modified risk labeling or advertising, participants' characteristics such as prior beliefs about the harmfulness of tobacco products, current use of tobacco products, and sociodemographic characteristics. Finally, the study would examine factors that may influence the effectiveness of debriefing at the end of a consumer perception study to ensure that people read and recall key information about the study. This research is significant because it will validate methods that can be used in studies of the impact of labels, labeling, and advertising on consumer perceptions and understanding of the risks of product use. Measures of consumer health risk perception will be developed and validated by conducting a study on two product types: Moist snuff smokeless tobacco products and electronic cigarette (e-cigarette) products. For each product type, we will assess individual-level factors that may moderate the impact of modified risk information on consumer responses. Potential moderating factors under study include: Beliefs (prior to viewing the modified risk information) about the harmfulness of tobacco products, and the strength with which those beliefs are held; current tobacco use behaviors; and sociodemographic characteristics including age and educational attainment. For each product type, participants will be randomized to view one of two conditions: Tobacco product labeling and advertising that either does or does not contain modified risk claims about a product. The labeling will consist of a product package. The [[Page 23466]] advertising will consist of a print advertisement. The study will assess participants' perceptions of various health risks from using the product, as well as their perceptions of health risk from using the product compared to smoking cigarettes, using nicotine replacement therapies, and quitting all tobacco and nicotine products. The study will also assess participants' intentions to use the product and their level of doubt about whether tobacco products are harmful to users' health. Measures of intentions and doubt will be used to help assess the validity of the measures of health risk perception. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Invitation: Young Adults (Ages 29,000 1 29,000 0.02 580 18-25)......................... Invitation: Adults (Ages 26+)... 29,000 1 29,000 0.02 580 Consent and Screener: Young 11,000 1 11,000 0.10 1,100 Adults (Ages 18-25)............ Consent and Screener: Adults 16,500 1 16,500 0.10 1,650 (Ages 26+)..................... Study: Young Adults (Ages 18-25) 3,300 1 3,300 0.33 1,089 Study: Adults (Ages 26+)........ 3,300 1 3,300 0.33 1,089 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 6,088 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on prior experience with research that is similar to this proposed study. Approximately 58,000 people will receive a study invitation, estimated to take 1 minute to read (approximately 0.02 hours), for a total of 1,160 hours for invitations. Approximately 27,500 people will complete the informed consent and screener to determine eligibility for participation in the study, estimated to take 6 minutes (0.10 hours), for a total of 2,750 hours for informed consent and screening activities. Approximately 6,600 people will complete the full study, estimated to take 20 minutes (approximately 0.33 hours), for a total of 2,178 hours for study completion activities. The estimated total hour burden of the collection of information is 6,088 hours. Dated: May 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10723 Filed 5-18-18; 8:45 am] BILLING CODE 4164-01-P
![23464 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
Disease.’’ The purpose of this guidance DEPARTMENT OF HEALTH AND that if you include your name, contact
is to assist sponsors in the clinical HUMAN SERVICES information, or other information that
development of drugs for the treatment identifies you in the body of your
or prevention of CMV disease in Food and Drug Administration comments, that information will be
patients who have undergone SOT or [Docket No. FDA–2018–N–0821] posted on https://www.regulations.gov.
HSCT. Specifically, this guidance • If you want to submit a comment
addresses FDA’s current thinking Agency Information Collection with confidential information that you
regarding the overall development Activities; Proposed Collection; do not wish to be made available to the
program and clinical trial designs for Comment Request; Investigation of public, submit the comment as a
the development of drugs and biologics Consumer Perceptions of Expressed written/paper submission and in the
to support an indication for the Modified Risk Claims manner detailed (see ‘‘Written/Paper
treatment or prevention of CMV disease Submissions’’ and ‘‘Instructions’’).
AGENCY: Food and Drug Administration,
in post-transplant populations. This HHS. Written/Paper Submissions
guidance does not address drug ACTION: Notice. Submit written/paper submissions as
development for the prevention or follows:
treatment of congenital CMV infection SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
or CMV infection in patients other than Administration (FDA or Agency) is written/paper submissions): Dockets
those undergoing SOT or HSCT. announcing an opportunity for public Management Staff (HFA–305), Food and
This guidance also discusses the use comment on the proposed collection of Drug Administration, 5630 Fishers
of CMV DNAemia (CMV certain information by the Agency. Lane, Rm. 1061, Rockville, MD 20852.
deoxyribonucleic acid in blood Under the Paperwork Reduction Act of • For written/paper comments
1995 (PRA), Federal Agencies are submitted to the Dockets Management
determined by polymerase chain
required to publish notice in the Staff, FDA will post your comment, as
reaction, an indirect measure of CMV
Federal Register concerning each well as any attachments, except for
viremia) as a surrogate endpoint in trials
proposed collection of information and information submitted, marked and
designed to support accelerated
to allow 60 days for public comment in identified, as confidential, if submitted
approval. response to the notice. This notice as detailed in ‘‘Instructions.’’
This draft guidance is being issued solicits comments on the investigation Instructions: All submissions received
consistent with FDA’s good guidance of consumer perceptions of expressed must include the Docket No. FDA–
practices regulation (21 CFR 10.115). modified risk claims. 2018–N–0821 for ‘‘Investigation of
The draft guidance, when finalized, will DATES: Submit either electronic or Consumer Perceptions of Expressed
represent the current thinking of FDA written comments on the collection of Modified Risk Claims.’’ Received
on developing drugs to treat or prevent information by July 20, 2018. comments, those filed in a timely
CMV disease in transplantation. It does ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed
not establish any rights for any person as follows. Please note that late, in the docket and, except for those
and is not binding on FDA or the public. untimely filed comments will not be submitted as ‘‘Confidential
You can use an alternative approach if considered. Electronic comments must Submissions,’’ publicly viewable at
it satisfies the requirements of the be submitted on or before July 20, 2018. https://www.regulations.gov or at the
applicable statutes and regulations. This The https://www.regulations.gov Dockets Management Staff between 9
guidance is not subject to Executive electronic filing system will accept a.m. and 4 p.m., Monday through
Order 12866. comments until midnight Eastern Time Friday.
at the end of July 20, 2018. Comments • Confidential Submissions—To
II. Paperwork Reduction Act of 1995 submit a comment with confidential
received by mail/hand delivery/courier
(for written/paper submissions) will be information that you do not wish to be
This draft guidance refers to
considered timely if they are made publicly available, submit your
previously approved collections of
postmarked or the delivery service comments only as a written/paper
information that are subject to review by
acceptance receipt is on or before that submission. You should submit two
the Office of Management and Budget
date. copies total. One copy will include the
(OMB) under the Paperwork Reduction information you claim to be confidential
Act of 1995 (44 U.S.C. 3501–3520). The Electronic Submissions with a heading or cover note that states
collections of information in 21 CFR ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the
parts 312 and 314 have been approved CONFIDENTIAL INFORMATION.’’ The
following way:
under OMB control numbers 0910–0014 • Federal eRulemaking Portal: Agency will review this copy, including
and 0910–0001, respectively. https://www.regulations.gov. Follow the the claimed confidential information, in
III. Electronic Access instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
Persons with access to the internet including attachments, to https:// claimed confidential information
may obtain the draft guidance at either www.regulations.gov will be posted to redacted/blacked out, will be available
https://www.fda.gov/Drugs/Guidance the docket unchanged. Because your for public viewing and posted on
ComplianceRegulatoryInformation/ comment will be made public, you are https://www.regulations.gov. Submit
Guidances/default.htm or https:// solely responsible for ensuring that your both copies to the Dockets Management
sradovich on DSK3GMQ082PROD with NOTICES
www.regulations.gov. comment does not include any Staff. If you do not wish your name and
Dated: May 15, 2018. confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Leslie Kux,
such as medical information, your or information on the cover sheet and not
Associate Commissioner for Policy. anyone else’s Social Security number, or in the body of your comments and you
[FR Doc. 2018–10733 Filed 5–18–18; 8:45 am] confidential business information, such must identify this information as
BILLING CODE 4164–01–P as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1](https://thefederalregister.org/doc/83_FR_23562/page/1.svg)
![23466 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
advertising will consist of a print smoking cigarettes, using nicotine products are harmful to users’ health.
advertisement. The study will assess replacement therapies, and quitting all Measures of intentions and doubt will
participants’ perceptions of various tobacco and nicotine products. The be used to help assess the validity of the
health risks from using the product, as study will also assess participants’ measures of health risk perception.
well as their perceptions of health risk intentions to use the product and their FDA estimates the burden of this
from using the product compared to level of doubt about whether tobacco collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Invitation: Young Adults (Ages 18–25) ................................ 29,000 1 29,000 0.02 580
Invitation: Adults (Ages 26+) ............................................... 29,000 1 29,000 0.02 580
Consent and Screener: Young Adults (Ages 18–25) .......... 11,000 1 11,000 0.10 1,100
Consent and Screener: Adults (Ages 26+) ......................... 16,500 1 16,500 0.10 1,650
Study: Young Adults (Ages 18–25) ..................................... 3,300 1 3,300 0.33 1,089
Study: Adults (Ages 26+) ..................................................... 3,300 1 3,300 0.33 1,089
Total .............................................................................. ........................ ........................ ........................ ........................ 6,088
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on committee is to provide advice and modifications before coming to the
prior experience with research that is recommendations to the Agency on meeting. For those unable to attend in
similar to this proposed study. FDA’s regulatory issues. At least one person, the meeting will also be
Approximately 58,000 people will portion of the meeting will be closed to available via webcast. The webcast will
receive a study invitation, estimated to the public. be available at the following link:
take 1 minute to read (approximately DATES: The meeting will be held on June https://collaboration.fda.gov/bpac0618/.
0.02 hours), for a total of 1,160 hours for 22, 2018, from 11 a.m. to 4:20 p.m. SUPPLEMENTARY INFORMATION:
invitations. Approximately 27,500 ADDRESSES: Great Room A, Building 31, Agenda: On June 22, 2018, in the
people will complete the informed FDA White Oak Campus, 10903 New morning open session, under Topic 1,
consent and screener to determine Hampshire Ave., Silver Spring, MD the Committee will hear presentations
eligibility for participation in the study, 20993. Answers to commonly asked on the research programs in the
estimated to take 6 minutes (0.10 hours), questions including information Laboratory of Emerging Pathogens
for a total of 2,750 hours for informed regarding special accommodations due (LEP), Laboratory of bacterial and TSE
consent and screening activities. to a disability, visitor parking, and Agents (LBTSE), and from the
Approximately 6,600 people will transportation may be accessed at: Laboratory of Molecular Virology (LMV)
complete the full study, estimated to https://www.fda.gov/Advisory in the Division of Emerging
take 20 minutes (approximately 0.33 Committees/AboutAdvisoryCommittees/ Transfusion-Transmitted Diseases
hours), for a total of 2,178 hours for ucm408555.htm. (DETTD), Office of Blood Research and
study completion activities. The Review (OBRR), Center for Biologics
estimated total hour burden of the FOR FURTHER INFORMATION CONTACT: Evaluation and Research (CBER), FDA.
collection of information is 6,088 hours. Bryan Emery or Joanne Lipkind, After the conclusion of the open
Division of Scientific Advisors and session, the meeting will be closed to
Dated: May 15, 2018.
Consultants, Center for Biologics permit discussion where disclosure
Leslie Kux, Evaluation and Research, Food and would constitute an unwarranted
Associate Commissioner for Policy. Drug Administration, 10903 New invasion of personal privacy in
[FR Doc. 2018–10723 Filed 5–18–18; 8:45 am] Hampshire Ave., Silver Spring, MD accordance with 5 U.S.C. 552b(c)(6).
BILLING CODE 4164–01–P 20993–0002, Bldg. 71, Rm. 6132, at 240– In the afternoon, in open session,
402–8054, bryan.emery@fda.hhs.gov under Topic II, the Committee will hear
and Rm. 6270, at 240–402–8106, presentations on the research program
DEPARTMENT OF HEALTH AND joanne.lipkind@fda.hhs.gov, in the Hemostasis Branch (HB), in the
HUMAN SERVICES respectively, or FDA Advisory Division of Plasma Protein Therapeutics
Committee Information Line, 1–800– (DPPT), Office of Tissues and Advanced
Food and Drug Administration
741–8138 (301–443–0572 in the Therapies (OTAT), Center for Biologics
[Docket No. FDA–2018–N–1708] Washington, DC area). A notice in the Evaluation and Research (CBER), FDA.
Federal Register about last minute After the open session, the meeting will
Blood Products Advisory Committee; modifications that impact a previously be closed to the public to permit
Notice of Meeting announced advisory committee meeting discussion where disclosure would
AGENCY: Food and Drug Administration, cannot always be published quickly constitute an unwarranted invasion of
enough to provide timely notice.
sradovich on DSK3GMQ082PROD with NOTICES
HHS. personal privacy in accordance with 5
ACTION: Notice. Therefore, you should always check the U.S.C. 552.b(c)(6).
Agency’s website at https:// FDA intends to make background
SUMMARY: The Food and Drug www.fda.gov/AdvisoryCommittees/ material available to the public no later
Administration (FDA) announces a default.htm and scroll down to the than 2 business days before the meeting.
forthcoming public advisory committee appropriate advisory committee meeting If FDA is unable to post the background
meeting of the Blood Products Advisory link, or call the advisory committee material on its website prior to the
Committee. The general function of the information line to learn about possible meeting, the background material will
VerDate Sep<11>2014 19:04 May 18, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1](https://thefederalregister.org/doc/83_FR_23562/page/3.svg)
Document Created: 2018-11-02 11:08:22
Document Modified: 2018-11-02 11:08:22
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by July 20, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 23464 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR