81 FR 80075 - Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 220 (November 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 220 (November 15, 2016)
| Page Range | 80075-80077 | |
| FR Document | 2016-27330 |
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)] [Notices] [Pages 80075-80077] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27330] [[Page 80075]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3710] Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a 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 creation of a cohort of cigarette smoking adults between the ages of 25 and 54 for the evaluation of FDA's point of sale tobacco education campaign. DATES: Submit either electronic or written comments on the collection of information by January 17, 2017. 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-2016-N-3710 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign.'' 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 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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. Evaluation of FDA's Point-of-Sale Public Education Campaign OMB Control Number--0910-NEW The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amends [[Page 80076]] the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing a tobacco education intervention at the point of sale to reduce the public health burden of tobacco use. The campaign features advertisements intended to encourage future quit attempts among current smokers in stores that sell tobacco products. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health, FDA requests OMB approval to collect information to evaluate the effectiveness of the point of sale tobacco education campaign. Data from this outcome evaluation study will be used to examine statistical associations between exposure to the campaign and specific outcomes of interest, which include awareness of the campaign and its messaging, campaign-related attitudes, beliefs and risk perceptions, motivation to quit smoking, self-efficacy for quitting, and increased intention to quit. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. Comprehensive evaluation of FDA's public education campaigns will be used to document whether the intended audience is aware of and understands campaign messages, and whether campaign exposure influences campaign-related attitudes, beliefs and risk perceptions, motivation to quit smoking, self-efficacy for quitting, and increased intention to quit. All of the information collected is integral to that evaluation. Evaluation of the Point of Sale Campaign. This outcome evaluation study will consist of three longitudinal data collection periods each lasting 3-4 months at 4 month intervals between data collection periods, with the first survey (Wave 1) occurring 3 months after campaign launch. Information will be collected from adult smokers, ages 25 to 54, about awareness of and exposure to campaign advertisements, tobacco use, and knowledge, attitudes, and beliefs related to tobacco use. Information will be collected on demographic variables including age, sex, race/ethnicity, and primary language. Participants will also be offered the option to download a smartphone application that will track their exposure to the campaign, and that will ask them to respond to a brief survey about every six months over the 18 month study period. FDA's media contractor has identified 52 potential counties for the campaign. From this list, FDA's evaluation contractor will randomly select 36 counties to be included in the evaluation. Of these, 24 counties will receive the intervention, while 12 counties will not receive it (control counties). Data will be collected from a longitudinal cohort that will consist of an entirely new sample of adult cigarette smokers. Addresses will be randomly selected from a predetermined list of U.S. counties and merged with household data on age and demographic characteristics commonly associated with smoking status in order to identify households that are likely to contain one or more adult smokers between the ages of 25 and 54. Pre-paid pre-addressed paper screening surveys will be mailed to approximately 71,875 (23,958 annualized) households that meet this criteria. For the purpose of calculating maximum burden, we assume that all 71,875 (23,958 annualized) households will be screened in one of two ways: (1) When an adult member of the household completes and returns the 10-minute screener they received by mail, or (2) during a 10 minute in-person screening interview conducted by trained field interviewers who visit all the addresses that do not return the screener. At 10 minutes per screening, the maximum potential burden hours for the mail screener is 12,219 (4,073 annualized). Accounting for nonresponse, we estimate that the mail and in-person screenings will result in 5,750 (1,917 annualized) adults who meet criteria for participation and complete the full Wave 1 survey. The Wave 1 survey will be completed during an in-person visit to the home, either as a stand-alone visit (for households that returned the mail screener) or immediately after the in-person screening is completed (for households that did not return the mail screener). We estimate that the Wave 1 survey will take 40 minutes to complete, resulting in 3,853 (1,284 annualized) burden hours. Adjusting for loss to follow-up between waves, we anticipate that 4,600 (1,533 annualized) participants will complete the Wave 2 survey, which will take 40 minutes and result in 3,082 (1,027 annualized) burden hours, and that 3,772 (1,257 annualized) participants will complete the Wave 3 survey, which will take 40 minutes and result in 2,527 (842 annualized) burden hours. Both the Wave 2 and 3 surveys will also be administered in person by trained interviewers. The total burden hours for all three in-person surveys will be 9,462 (3,154 annualized). We anticipate that approximately \2/3\ of the participants (3,833 people [1,278 annualized]) who complete the Wave 1 survey will download a smartphone application that will deliver additional surveys to them starting one month after the end of the first data collection. These participants will complete 3 surveys lasting 5 minutes each (every 6 months over the course of 18 months), resulting in 307 (102 annualized) burden hours per app-based survey and 921 (307 annualized) burden hours total for all of the app-based surveys. The total burden hours for the screener, 3 in-person surveys, and 3 app-based surveys is 22,600 (7,533 annualized). Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of Total Type of respondent Activity No. of responses per annual Average burden per response Total respondents respondent responses hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Households.............................. Screener.................... 23,958 1 23,958 0.17 (10 minutes).......... 4,073 Adults smokers ages 25 to 54............ Wave 1 questionnaire 1,917 1 1,917 0.67 (40 minutes).......... 1,284 (Current smokers). Wave 2 questionnaire........ 1,533 1 1,533 0.67 (40 minutes).......... 1,027 Wave 3 questionnaire........ 1,257 1 1,257 0.67 (40 minutes).......... 842 Study participants (opt in)............. App-based survey............ 1,278 3 3,834 0.08 (5 minutes)........... 307 Totals.............................. ............................ ........... .............. 32,499 ........................... 7,533 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 80077]] Dated: November 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27330 Filed 11-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices 80075
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). default.htm.
Docket: For access to the docket to
Food and Drug Administration Written/Paper Submissions read background documents or the
Submit written/paper submissions as electronic and written/paper comments
[Docket No. FDA–2016–N–3710] follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Agency Information Collection written/paper submissions): Division of docket number, found in brackets in the
Activities; Proposed Collection; Dockets Management (HFA–305), Food heading of this document, into the
Comment Request; Evaluation of the and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Food and Drug Administration’s Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Education at the Point of Sale • For written/paper comments Management, 5630 Fishers Lane, Rm.
Campaign submitted to the Division of Dockets 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Management, FDA will post your FOR FURTHER INFORMATION CONTACT: FDA
HHS. comment, as well as any attachments, PRA Staff, Office of Operations, Food
except for information submitted, and Drug Administration, Three White
ACTION: Notice. marked and identified, as confidential,
Flint North, 10A63, 11601 Landsdown
SUMMARY: The Food and Drug if submitted as detailed in
St., North Bethesda, MD 20852,
Administration (FDA) is announcing an ‘‘Instructions.’’
Instructions: All submissions received PRAStaff@fda.hhs.gov.
opportunity for public comment on the SUPPLEMENTARY INFORMATION: Under the
must include the Docket No. FDA–
proposed collection of certain PRA (44 U.S.C. 3501–3520), Federal
2016–N–3710 for ‘‘Agency Information
information by the Agency. Under the Agencies must obtain approval from the
Collection Activities; Proposed
Paperwork Reduction Act of 1995 (the Office of Management and Budget
Collection; Comment Request;
PRA), Federal Agencies are required to (OMB) for each collection of
Evaluation of the Food and Drug
publish a notice in the Federal Register information they conduct or sponsor.
Administration’s Education at the Point
concerning each proposed collection of ‘‘Collection of information’’ is defined
of Sale Campaign.’’ Received comments
information, and to allow 60 days for will be placed in the docket and, except in 44 U.S.C. 3502(3) and 5 CFR
public comment in response to the for those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
notice. This notice solicits comments on Submissions,’’ publicly viewable at or requirements that members of the
the creation of a cohort of cigarette http://www.regulations.gov or at the public submit reports, keep records, or
smoking adults between the ages of 25 Division of Dockets Management provide information to a third party.
and 54 for the evaluation of FDA’s point between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
of sale tobacco education campaign. through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or • Confidential Submissions—To Agencies to provide a 60-day notice in
written comments on the collection of submit a comment with confidential the Federal Register concerning each
information by January 17, 2017. information that you do not wish to be proposed collection of information
ADDRESSES: You may submit comments made publicly available, submit your before submitting the collection to OMB
as follows: comments only as a written/paper for approval. To comply with this
submission. You should submit two requirement, FDA is publishing notice
Electronic Submissions copies total. One copy will include the of the proposed collection of
Submit electronic comments in the information you claim to be confidential information set forth in this document.
following way: with a heading or cover note that states With respect to the following
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS collection of information, FDA invites
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The comments on these topics: (1) Whether
instructions for submitting comments. Agency will review this copy, including the proposed collection of information
Comments submitted electronically, the claimed confidential information, in is necessary for the proper performance
including attachments, to http:// its consideration of comments. The of FDA’s functions, including whether
www.regulations.gov will be posted to second copy, which will have the the information will have practical
the docket unchanged. Because your claimed confidential information utility; (2) the accuracy of FDA’s
comment will be made public, you are redacted/blacked out, will be available estimate of the burden of the proposed
solely responsible for ensuring that your for public viewing and posted on http:// collection of information, including the
comment does not include any www.regulations.gov. Submit both validity of the methodology and
confidential information that you or a copies to the Division of Dockets assumptions used; (3) ways to enhance
third party may not wish to be posted, Management. If you do not wish your the quality, utility, and clarity of the
such as medical information, your or name and contact information to be information to be collected; and (4)
anyone else’s Social Security number, or made publicly available, you can ways to minimize the burden of the
confidential business information, such provide this information on the cover collection of information on
as a manufacturing process. Please note sheet and not in the body of your respondents, including through the use
that if you include your name, contact comments and you must identify this of automated collection techniques,
information, or other information that information as ‘‘confidential.’’ Any when appropriate, and other forms of
identifies you in the body of your information marked as ‘‘confidential’’ information technology.
mstockstill on DSK3G9T082PROD with NOTICES
comments, that information will be will not be disclosed except in Evaluation of FDA’s Point-of-Sale Public
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other Education Campaign
• If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of OMB Control Number—0910–NEW
do not wish to be made available to the comments to public dockets, see 80 FR The 2009 Family Smoking Prevention
public, submit the comment as a 56469, September 18, 2015, or access and Tobacco Control Act (Tobacco
written/paper submission and in the the information at: http://www.fda.gov/ Control Act) (Pub. L. 111–31) amends
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![80076 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
the Federal Food, Drug, and Cosmetic study will consist of three longitudinal interview conducted by trained field
Act (the FD&C Act) to grant FDA data collection periods each lasting 3– interviewers who visit all the addresses
authority to regulate the manufacture, 4 months at 4 month intervals between that do not return the screener. At 10
marketing, and distribution of tobacco data collection periods, with the first minutes per screening, the maximum
products to protect public health and to survey (Wave 1) occurring 3 months potential burden hours for the mail
reduce tobacco use by minors. Section after campaign launch. Information will screener is 12,219 (4,073 annualized).
1003(d)(2)(D) of the FD&C Act (21 be collected from adult smokers, ages 25 Accounting for nonresponse, we
U.S.C. 393(d)(2)(D)) supports the to 54, about awareness of and exposure estimate that the mail and in-person
development and implementation of to campaign advertisements, tobacco screenings will result in 5,750 (1,917
FDA public education campaigns use, and knowledge, attitudes, and annualized) adults who meet criteria for
related to tobacco use. Accordingly, beliefs related to tobacco use. participation and complete the full
FDA is currently developing and Information will be collected on Wave 1 survey. The Wave 1 survey will
implementing a tobacco education demographic variables including age, be completed during an in-person visit
intervention at the point of sale to sex, race/ethnicity, and primary to the home, either as a stand-alone visit
reduce the public health burden of language. Participants will also be (for households that returned the mail
tobacco use. The campaign features offered the option to download a screener) or immediately after the in-
advertisements intended to encourage smartphone application that will track person screening is completed (for
future quit attempts among current their exposure to the campaign, and that households that did not return the mail
smokers in stores that sell tobacco will ask them to respond to a brief screener). We estimate that the Wave 1
products. survey about every six months over the survey will take 40 minutes to complete,
In support of the provisions of the 18 month study period. resulting in 3,853 (1,284 annualized)
Tobacco Control Act that require FDA to FDA’s media contractor has identified burden hours. Adjusting for loss to
protect the public health, FDA requests 52 potential counties for the campaign. follow-up between waves, we anticipate
OMB approval to collect information to From this list, FDA’s evaluation that 4,600 (1,533 annualized)
evaluate the effectiveness of the point of contractor will randomly select 36 participants will complete the Wave 2
sale tobacco education campaign. Data counties to be included in the survey, which will take 40 minutes and
from this outcome evaluation study will evaluation. Of these, 24 counties will result in 3,082 (1,027 annualized)
be used to examine statistical receive the intervention, while 12 burden hours, and that 3,772 (1,257
associations between exposure to the counties will not receive it (control annualized) participants will complete
campaign and specific outcomes of counties). the Wave 3 survey, which will take 40
interest, which include awareness of the Data will be collected from a minutes and result in 2,527 (842
campaign and its messaging, campaign- longitudinal cohort that will consist of annualized) burden hours. Both the
related attitudes, beliefs and risk an entirely new sample of adult Wave 2 and 3 surveys will also be
perceptions, motivation to quit smoking, cigarette smokers. Addresses will be administered in person by trained
self-efficacy for quitting, and increased randomly selected from a interviewers. The total burden hours for
intention to quit. predetermined list of U.S. counties and all three in-person surveys will be 9,462
Evaluation is an essential merged with household data on age and (3,154 annualized).
organizational practice in public health demographic characteristics commonly We anticipate that approximately 2⁄3
and a systematic way to account for and associated with smoking status in order of the participants (3,833 people [1,278
improve public health actions. to identify households that are likely to annualized]) who complete the Wave 1
Comprehensive evaluation of FDA’s contain one or more adult smokers survey will download a smartphone
public education campaigns will be between the ages of 25 and 54. Pre-paid application that will deliver additional
used to document whether the intended pre-addressed paper screening surveys surveys to them starting one month after
audience is aware of and understands will be mailed to approximately 71,875 the end of the first data collection.
campaign messages, and whether (23,958 annualized) households that These participants will complete 3
campaign exposure influences meet this criteria. For the purpose of surveys lasting 5 minutes each (every 6
campaign-related attitudes, beliefs and calculating maximum burden, we months over the course of 18 months),
risk perceptions, motivation to quit assume that all 71,875 (23,958 resulting in 307 (102 annualized)
smoking, self-efficacy for quitting, and annualized) households will be burden hours per app-based survey and
increased intention to quit. All of the screened in one of two ways: (1) When 921 (307 annualized) burden hours total
information collected is integral to that an adult member of the household for all of the app-based surveys. The
evaluation. completes and returns the 10-minute total burden hours for the screener, 3 in-
Evaluation of the Point of Sale screener they received by mail, or (2) person surveys, and 3 app-based
Campaign. This outcome evaluation during a 10 minute in-person screening surveys is 22,600 (7,533 annualized).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Total
No. of Average burden per Total
Type of respondent Activity responses per annual
respondents response hours
respondent responses
Households ............................. Screener ............................... 23,958 1 23,958 0.17 (10 minutes) .... 4,073
mstockstill on DSK3G9T082PROD with NOTICES
Adults smokers ages 25 to 54 Wave 1 questionnaire (Cur- 1,917 1 1,917 0.67 (40 minutes) .... 1,284
rent smokers).
Wave 2 questionnaire ........... 1,533 1 1,533 0.67 (40 minutes) .... 1,027
Wave 3 questionnaire ........... 1,257 1 1,257 0.67 (40 minutes) .... 842
Study participants (opt in) ...... App-based survey ................. 1,278 3 3,834 0.08 (5 minutes) ...... 307
Totals ............................... ............................................... .................... ........................ 32,499 .................................. 7,533
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices 80077
Dated: November 8, 2016. development or approval, of any drug are registered with FDA, and that the
Leslie Kux, product. Section 306(a)(2)(B) of the labeling of such drugs bears true and
Associate Commissioner for Policy. FD&C Act requires debarment of an accurate information.
[FR Doc. 2016–27330 Filed 11–14–16; 8:45 am] individual if FDA finds that the As a result of this conviction, FDA
BILLING CODE 4164–01–P
individual has been convicted of a sent Mr. Smith by certified mail on
felony under Federal law for conduct August 5, 2016, a notice proposing to
otherwise relating to the regulation of permanently debar him from providing
DEPARTMENT OF HEALTH AND any drug product under the FD&C Act. services in any capacity to a person that
HUMAN SERVICES On October 27, 2015, the U.S. District has an approved or pending drug
Court for the Eastern District of product application. The proposal was
Food and Drug Administration Washington entered judgment against based on a finding, under section
Mr. Smith for one count of conspiracy, 306(a)(2) of the FD&C Act, that Mr.
[Docket No. FDA–2016–N–1162]
in violation of 18 U.S.C. 371, three Smith was convicted of felonies under
Louis Daniel Smith: Debarment Order counts of introducing misbranded drugs Federal law for conduct relating to the
into interstate commerce with intent to development or approval, including the
AGENCY: Food and Drug Administration, defraud or mislead, in violation of process for development or approval, of
HHS. section 301(a) of the FD&C Act (21 a drug product, or conduct otherwise
ACTION: Notice. U.S.C. 331(a)), which according to relating to the regulation of a drug
section 303(a)(2) of the FD&C Act (21 product under the FD&C Act. The
SUMMARY: The U.S. Food and Drug U.S.C. 333(a)(2)) constitutes a felony, proposal also offered Mr. Smith an
Administration (FDA or Agency) is and one count of smuggling in violation opportunity to request a hearing,
issuing an order under the Federal of 18 U.S.C. 545. providing him 30 days from the date of
Food, Drug, and Cosmetic Act (the The factual basis for this conviction is receipt of the letter in which to file the
FD&C Act) permanently debarring Louis as follows: Mr. Smith was a managing request, and advised him that failure to
Daniel Smith from providing services in member of PGL International, LLC request a hearing constituted a waiver of
any capacity to a person that has an (PGL), and served as the director of the opportunity for a hearing and of any
approved or pending drug product PGL’s operations. PGL is a Nevada contentions concerning this action. Mr.
application. FDA bases this order on a corporation, which marketed and sold Smith received the proposal on August
finding that Mr. Smith was convicted of various health-related products, 8, 2016. Mr. Smith did not request a
felonies under Federal law for conduct including Miracle Mineral Solution hearing and has, therefore, waived his
relating to the development or approval, (MMS), a mixture of sodium chlorite opportunity for a hearing and any
including the process for development and water. Sodium chlorite is an contentions concerning his debarment
or approval, of a drug product, or industrial chemical used as a pesticide (21 CFR part 12).
otherwise relating to the regulation of a and for hydraulic fracking and
wastewater treatment. Sodium chlorite II. Findings and Order
drug product under the FD&C Act. Mr.
Smith was given notice of the proposed cannot be sold for human consumption Therefore, the Director, Office of
permanent debarment and an and suppliers of the chemical include a Enforcement and Import Operations,
opportunity to request a hearing within warning sheet stating that it can cause Office of Regulatory Affairs, under
the timeframe prescribed by regulation. potentially fatal side effects if section 306(a)(2) of the FD&C Act, under
Mr. Smith failed to respond. Mr. Smith’s swallowed. Mr. Smith obtained authority delegated to him (Staff Manual
failure to respond constitutes a waiver chemicals needed to manufacture the Guide 1410.35), finds that Louis Daniel
of his right to a hearing concerning this misbranded drug MMS without Smith has been convicted of felonies
action. revealing to regulators and suppliers the under Federal law for conduct relating
true purpose of the chemicals; used to the development or approval,
DATES: This order is effective November
those chemicals to manufacture the including the process for development
15, 2016.
misbranded drug MMS in a facility that or approval, of a drug product, or
ADDRESSES: Submit applications for conduct otherwise relating to the
was not disclosed to regulators; offered
special termination of debarment to the the misbranded drug MMS for sale on regulation of a drug product under the
Division of Dockets Management (HFA– Web sites Mr. Smith had established; FD&C Act.
305), Food and Drug Administration, and sold that drug in interstate As a result of the foregoing finding,
5630 Fishers Lane, Rm. 1061, Rockville, commerce. Louis Daniel Smith is permanently
MD 20852. From on or about September 11, 2004, debarred from providing services in any
FOR FURTHER INFORMATION CONTACT: to at least on or about July 16, 2012, in capacity to a person with an approved
Kenny Shade, Division of Enforcement, the Eastern District of Washington and or pending drug product application
Office of Enforcement and Import elsewhere, Mr. Smith introduced, under sections 505, 512, or 802 of the
Operations, Office of Regulatory Affairs delivered for introduction into interstate FD&C Act (21 U.S.C. 355, 360b, or 382),
(ELEM–4144), Food and Drug commerce, and caused the introduction or under section 351 of the Public
Administration, 12420 Parklawn Dr., and delivery for introduction into Health Service Act (42 U.S.C. 262),
Rockville, MD 20857, 301–796–4640. interstate commerce, with the intent to effective (see DATES) (see section
SUPPLEMENTARY INFORMATION: defraud or mislead, misbranded drugs. 201(dd) (21 U.S.C. 321(dd)),
In addition, he knowingly defrauded the 306(c)(1)(B), and 306(c)(2)(A)(ii) of the
I. Background United States and also impeded the FD&C Act). Any person with an
mstockstill on DSK3G9T082PROD with NOTICES
Section 306(a)(2)(A) of the FD&C Act lawful government functions of FDA, approved or pending drug product
(21 U.S.C. 335a(a)(2)(A)) requires specifically, FDA’s duty to protect the application who knowingly employs or
debarment of an individual if FDA finds health and safety of the public by, retains as a consultant or contractor, or
that the individual has been convicted among other things, ensuring that drugs otherwise uses the services of Louis
of a felony under Federal law for marketed in the United States are safe Daniel Smith, in any capacity during his
conduct relating to the development or and effective for their intended uses and debarment, will be subject to civil
approval, including the process for are manufactured in establishments that money penalties (section 307(a)(6) of the
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Document Created: 2016-11-15 00:48:03
Document Modified: 2016-11-15 00:48:03
| 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 January 17, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 80075 |
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