Notice2021-19061
Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Supply Chain Security Act Implementation
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Published
September 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 86 Issue 169 (Friday, September 3, 2021)</title>
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[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49538-49542]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19061]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Drug Supply Chain Security Act Implementation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by November 2, 2021.
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 November 2, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 2, 2021. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2014-D-0609 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Drug Supply Chain Security Act
Implementation.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential
[[Page 49539]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#702022312304111616301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including
each proposed extension of an existing 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.
Drug Supply Chain Security Act Implementation
OMB Control Number 0910-0806--Revision
This information collection helps to support implementation of
section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1). Enacted in 2013, the Drug Supply Chain Security Act
(DSCSA) (Title II of Pub. L. 113-54) amended section 582 of the FD&C
Act and outlines steps to build an electronic, interoperable system to
identify and trace certain prescription drugs as they are distributed
in the United States. The DSCSA is intended to enhance FDA's ability to
help protect consumers from exposure to drugs that may be counterfeit,
stolen, contaminated, or otherwise harmful. Respondents to the
information collection are manufacturers, wholesalers, dispensers, and
repackagers, as defined in section 581 of the FD&C Act (21 U.S.C.
360eee), of pharmaceutical drug products.
To assist respondents with statutory requirements set forth in
section 582 pertaining to notifications of illegitimate products or
products with a high risk of illegitimacy, we developed Form FDA 3911
entitled ``Drug Notification'' along with the corresponding
instructional document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--
DRUG NOTIFICATION.'' Form FDA 3911 and the instructions are available
from, and may be completed using, our website at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions</a>. Form FDA 3911 is intended to facilitate
notifications governed by section 582 by providing a uniform format for
initial notifications, followup notifications, and requests for the
termination of a notification.
Section 582 of the FD&C Act also provides for FDA issuance of
guidance documents to facilitate implementation of the DSCSA. To that
end, we continue to develop guidance documents to assist respondents
with information collection provisions set forth in section 582. The
procedural guidance document entitled ``Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification''
(June 2021; available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification</a>) is
intended to assist respondents in identifying suspect products, as
defined at section 581, and with terminating notifications of
illegitimate product or products with a high risk of illegitimacy. As
explained in the guidance document, beginning January 1, 2015, certain
trading partners (i.e., manufacturers, repackagers, wholesale
distributors, or dispensers), upon determining that a product in their
possession or control is a suspect product, must quarantine the product
while they promptly conduct an investigation to determine whether the
product is an illegitimate product, must notify FDA if they determine
that the product is illegitimate product, and must notify certain
trading partners of the illegitimate product as prescribed by section
582. Manufacturers must also notify FDA and certain immediate trading
partners after determining that a product in their possession or
control has a high risk of being illegitimate product.
Similarly, we developed the draft guidance document ``Waivers,
Exceptions, and Exemptions From the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' (May 2018; available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act</a>). The draft guidance explains Agency
established processes by which: (1) A trading partner may request a
waiver from certain requirements in section 582 if it would result in
an undue economic hardship or for emergency medical reasons; (2) a
manufacturer or repackager may request an exception to
[[Page 49540]]
the section 582 requirements related to product identifiers if a
product is packaged in a container too small or otherwise unable to
accommodate a label with sufficient space to bear the required
information; and (3) FDA may determine other products or transactions
that shall be exempt from requirements of section 582.
FDA has recently published the draft guidance document ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act'' (June 2021; available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act</a>). The draft guidance clarifies the enhanced system requirements
listed in section 582(g)(1) of the FD&C Act. This draft guidance also
outlines and provides recommendations on the system attributes
necessary for enabling the secure tracing of product at the package
level, including allowing for the use of verification, inference, and
aggregation, as necessary. FDA has also published a draft guidance
document entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information'' (November 2014; available
at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs</a>). This draft guidance
establishes initial standards for the interoperable exchange of product
tracing information, in paper or electronic format, for compliance with
sections 582(a) through (e) of the FD&C Act.
Two additional guidance documents help to further explain the
statutory requirements of section 582. The ``Product Identifiers under
the Drug Supply Chain Security Act--Questions and Answers'' guidance
for industry (June 2021; available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers</a>) is intended to
address anticipated questions regarding product identifiers that are
required under section 582 for packages and homogenous cases of certain
drug products. The ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs'' draft guidance (October
2018; available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs</a>) provides recommendations for a
robust verification system for the determination, quarantine, and
investigation of suspect products, as well as the quarantine,
notification, and disposition of illegitimate products. The guidance
also addresses FDA's recommendation that trading partners submit
cleared product notifications. Finally, the guidance addresses the
statutory requirements for verification, including verification of
saleable returns, at the package level for product identifiers on
packages and homogenous cases intended to be introduced in a
transaction into commerce.
FDA guidance documents are issued consistent with requirements
found in section 582, as well as our Good Guidance Practice regulations
found in 21 CFR 10.115, which provide for public comment at any time.
In addition, since enactment of the DSCSA, our Center for Drug
Evaluation and Research has developed and continues to maintain a
website communicating DSCSA implementation activity, including relevant
resources at: <a href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa">https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa</a>.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden--Notifications to FDA \1\
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Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
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Manufacturers and Repackagers... 100 1 100 1 100
Wholesale Distributors.......... 138 1 138 1 138
Dispenser....................... 12 1 12 1 12
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Total....................... .............. .............. 250 .............. 250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
Product \1\
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Number of
Type of respondent Number of disclosures Total Average time Total hours
respondents per respondent disclosures per disclosure
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Manufacturers and Repackagers... 100 30 3,000 * 0.20 600
Wholesale Distributors.......... 138 1,175 162,150 * 0.20 32,430
Dispensers...................... 12 2 24 * 0.20 5
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Total....................... .............. .............. 165,174 .............. 33,035
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (12 minutes.)
[[Page 49541]]
Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
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Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
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Manufacturers and Repackagers... 100 1 100 1 100
Wholesale Distributors.......... 138 1 138 1 138
Dispensers...................... 12 1 12 1 12
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Total....................... .............. .............. 250 .............. 250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
Product Termination \1\
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Number of
Type of respondent Number of disclosures Total Average time Total hours
respondents per respondent disclosures per disclosure
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Manufacturers and Repackagers... 100 30 3,000 * 0.20 600
Wholesale Distributors.......... 138 1,175 162,150 * 0.20 32,430
Dispensers...................... 12 2 24 * 0.20 5
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Total....................... .............. .............. 165,174 .............. 33,035
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (12 minutes.)
Table 5--Estimated Annual Reporting Burden for Requests for Waivers, Exceptions, or Exemptions \1\
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Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
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Requests to FDA for a Waiver, 20 1 20 80 1,600
Exception, or Exemption........
Notifications to FDA of a 1 1 1 16 16
Material Change in
Circumstances Warranting the
Waiver, Exception, or Exemption
Requests to FDA to Renew a 1 1 1 16 16
Waiver, Exception, or Exemption
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Total....................... .............. .............. 22 .............. 1,632
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on illegitimate product notifications already received, we
estimate a total of 250 respondents to the information collection. Our
database for establishment and drug product listing suggests that many
companies perform activities of both manufacturers and repackagers and
therefore we have combined our estimated number of respondent
manufacturers and repackagers. In addition, because statutory
provisions specifically define ``dispensers'' to include retail
pharmacies, hospital pharmacies, and groups of chain pharmacies, our
estimate of the number of dispensers is intended to reflect the overall
estimated number of respondents we believe to be subject to the
requirements under section 582(d) of the FD&C Act. Because
manufacturers, repackagers, and wholesale distributors are collectively
responsible for prescription drugs from the point of manufacturing
through distribution in the drug supply chain, we assume that these
three trading partners submit most notifications of illegitimate
products. Upon evaluation of those notifications received in fiscal
year (FY) 2020 and, thus far, in FY 2021, we assume those 250
respondents are comprised of 40 percent manufacturers (100), 55 percent
wholesale distributors (138), and 5 percent pharmacies (12). We assume
that annual notifications will vary from zero to two for manufacturers
and repackagers, as well as from pharmacies, but that most of companies
will make no notifications. Although our establishment and drug product
listing database currently reflects approximately 1,400 manufacturers
and repackagers, we estimate only 100 manufacturers and repackagers
will notify us of illegitimate products an average of one time per
year.
Relying on data from the National Association of Chain Drug Stores,
the National Community Pharmacists Association, and the American
Hospital Association, we assume there are approximately 67,000 pharmacy
sites in the United States. Based on a review of data, we estimate 12
pharmacies will notify FDA of illegitimate product an average of 1 time
per year.
According to the Healthcare Distribution Alliance (formerly known
as Healthcare Distribution Management Association), approximately 30
wholesale distributors are responsible for over 90 percent of drug
distributions. Based on sales, and because FDA is estimating that over
1,570 small wholesale distributors may be responsible for the remaining
10 percent of drug sales, we estimate that wholesale distributors will
be responsible for making approximately an average of 1 notification
per year to account for the estimated 138 notifications that FDA will
receive regarding illegitimate product. We
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assume wholesale distributors will expend 1 hour for each notification.
Because the extent of distribution of any illegitimate product will
vary, we assume a wide distribution for each illegitimate product for
purposes of establishing our burden estimate. We estimate that, for
each notification that a manufacturer or repackager makes to FDA, the
manufacturer or repackager will notify approximately 30 trading
partners (relying on the number of distributors). This formula results
in approximately 3,000 notifications annually to trading partners of
manufacturers and repackagers. This estimate includes the notifications
by manufacturers and repackagers who have determined that an
illegitimate product is in their possession or control, as well as
notifications by manufacturers who have determined that a product poses
a high risk of illegitimacy.
We assume that a large wholesale distributor may have up to 4,500
trading partners, where a small wholesale distributor may have 200
trading partners, averaging approximately 2,350. We had originally
estimated that a wholesale distributor would notify all 2,350 trading
partners for each of the illegitimate products identified. However, as
a result of our experience with the collection and informal feedback
from industry, we have lowered our estimate to reflect that 138
respondents will make 1,175 disclosures for a total of 162,150
disclosures annually and that each disclosure will require
approximately 12 minutes, for a total of 32,430 hours annually.
We estimate that a pharmacy purchases prescription drugs from an
average of two wholesale distributors. Therefore, a pharmacy would
notify 2 trading partners for each of the 12 illegitimate products
identified. This estimate results in in approximately 24 notifications
annually to pharmacy trading partners.
We estimate that the burden for notifying trading partners of an
illegitimate product and the number of trading partners notified will
be the same as the estimates for notification of termination. The
estimated total burden hours to notify trading partners that the
notification is terminated is approximately 33,035 hours annually.
We assume a comparable amount of time is required to provide the
information necessary for requesting to terminate a notification. The
time required to investigate and resolve an illegitimate product
notification will vary, but we assume that each notification will
eventually be terminated. We assume that the number of requests for
termination of a notification per year will be the same as the original
number of notifications for a given year. The estimated total burden
hours to make requests for termination of notifications to FDA is 250
hours annually.
Based on communications we have had with trading partners and
stakeholders since the 2013 enactment of the DSCSA, we estimate that 20
trading partners or stakeholders will submit approximately 20 requests
for a waiver, an exception, or an exemption. Also based on feedback
from industry stakeholders, we estimate that respondents will expend an
average of 80 hours to prepare and submit each request and to submit
any additional followup information that we may request. We estimate
the total burden as approximately 1,600 hours.
We estimate that we will receive from approximately one respondent
approximately one notification or other information informing us that
there has or has not been a material change in the circumstances that
warranted the waiver, exception, or exemption and that each
notification will require approximately 16 hours to prepare and submit
to us. We estimate the total burden as approximately 16 hours.
We estimate that we will receive approximately one renewal request
from approximately one respondent and that each request will require
approximately 16 hours to prepare and submit to us. We estimate the
total burden as approximately 16 hours.
Our estimated burden for the information collection reflects an
overall increase of 56,116 hours and a corresponding increase of
271,638 responses annually. We attribute this adjustment to an increase
in the number of illegitimate product notification submissions we
received in the last couple of years and the number of such submissions
we have received so far this fiscal year.
Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19061 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P
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