Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop, 10259-10260 [2016-04221]

Download as PDF 10259 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices survey, respondents will be randomly assigned to view one of two ads for fictional prescription drugs intended to treat high cholesterol. They will be asked questions about FDA’s authority regarding specific claims within the ad. The survey will include a debriefing to inform respondents that the advertised drug was fictitious. We will also measure other potentially important nonresponse. We will examine the frequencies for survey items and the relation between survey items and demographic and health characteristics. We also plan to compare responses between this survey and FDA’s 2002 survey for repeated items. FDA estimates the burden of this collection of information as follows: characteristics such as demographics, insurance coverage, and prescription drug use. The survey is available upon request. We will test for any differences between modes (online versus mail survey) and will account for any mode effects in our analyses. We will weigh the data to account for different probability of selection and TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pilot Study Survey invitation letter .......................................... Reminder postcard ............................................... Non-response letter .............................................. Non-response questionnaire letter ....................... Second postcard .................................................. Survey .................................................................. 100 100 82 81 60 35 1 1 1 1 1 1 100 100 82 81 60 35 .08 .03 .08 .08 .03 .33 (5 min.) .................... (2 min.) .................... (5 min.) .................... (5 min.) .................... (2 min.) .................... (20 min.) .................. 8 3 7 7 2 12 .08 .03 .08 .08 .03 .33 (5 min.) .................... (2 min.) .................... (5 min.) .................... (5 min.) .................... (2 min.) .................... (20 min.) .................. 403 151 334 326 92 582 ....................................... 1927 Main Study Survey invitation letter .......................................... Reminder postcard ............................................... Non-response letter .............................................. Non-response questionnaire letter ....................... Second postcard .................................................. Survey .................................................................. 5,042 5,042 4,173 4,073 3,063 1,765 1 1 1 1 1 1 5,042 5,042 4,173 4,073 3,063 1,765 Total .............................................................. ........................ ........................ ........................ 1 There are no capital costs or operating and maintenance costs associated with this collection of information. References asabaliauskas on DSK5VPTVN1PROD with NOTICES The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http:// www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ‘‘Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs— Summary of FDA Survey Research Results’’ (2004). (http://www.fda.gov/ downloads/Drugs/ScienceResearch/ ResearchAreas/DrugMarketing AdvertisingandCommunications Research/ucm152860.pdf). 2. PhRMA Guiding Principles: Direct-toConsumer Advertisements About Prescription Medicines (2008). (http:// phrma.org/sites/default/files/pdf/phrma guidingprinciplesdec08final.pdf). 3. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone, Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed. Hoboken, NJ: John Wiley & Sons, Inc. (2014). VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 4. American Association for Public Opinion Research, ‘‘Address-based Sampling’’ (2016). (http://www.aapor.org/AAPOR_ Main/media/MainSiteFiles/AAPOR_ Report_1_7_16_CLEAN–COPY– FINAL.pdf). 5. Millar, M.M. and D.A. Dillman, ‘‘Improving Response to Web and MixedMode Surveys,’’ Public Opinion Quarterly 1–21 (2011). 6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and S.A. Adlis, ‘‘The Use of Monetary Incentives in a Community Survey: Impact on Response Rates, Data Quality, and Cost,’’ Health Services Research 35:1339–1346 (2011). 7. Montaquila, J.M., J.M. Brick, D. Williams, K. Kim, et al., ‘‘A Study of Two-Phase Mail Survey Data Collection Methods, Journal of Survey Statistics and Methodology 1(1), 66–87 (2013). Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04220 Filed 2–26–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Medical Devices—Quality Systems Survival: Success Strategies for Production and Process Controls/ Corrective and Preventative Action; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office, in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled ‘‘Medical Devices— Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action’’. The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire SUMMARY: E:\FR\FM\29FEN1.SGM 29FEN1 10260 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to insure compliance with FDA regulations. DATES: The meeting will be held on April 15, 2016, from 8 a.m. to 5 p.m. ADDRESSES: The meeting will be held at Courtyard and Towne Place Suites by Marriott, DFW Airport North/Grapevine, 2200 Bass Pro Ct., Grapevine, TX 76051. Directions and lodging information are available at the FMDIC, Inc. Web site at http://www.fmdic.org/. FOR FURTHER INFORMATION CONTACT: Staci McAllister, Consumer Safety Technician, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214–253–5259, FAX: 214–253– 5314, staci.mcallister@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES I. Background The workshop is being held in response to the interest in the topics discussed from small medical device manufacturers in the Dallas District area. This workshop helps achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) as an outreach activity by Government agencies to small businesses. The goal of the public workshop is to present information that will enable manufacturers and regulated industry to better comply with FDA’s medical device requirements. Please visit the http://www.fmdic.org/ Web site for the agenda and for information about the presenters at the workshop. II. Participation in the Public Workshop Registration: FMDIC has early registration ($250 for industry/$150 for government with ID/$50 for students) available until March 14, 2016. Registration after March 14, 2016, increases to $300 for industry, $200 for government with ID, with student registration staying the same, at $50. To register online, please visit http:// www.fmdic.org/. As an alternative, send the registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 the FMDIC, Inc., to FMDIC Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX 75205. FMDIC, Inc. accepts registrations onsite on the day of the event beginning at 7:30 a.m. at the regular registration fee stated above. Registration on site will be accepted on a space available basis on the day of the public workshop beginning at 7:30 a.m. Please note that due to popularity, similar past events have reached maximum capacity well before the day of the event. The cost of registration at the site is $300 payable to the FMDIC, Inc. The registration fee will be used to offset expenses of hosting the event, including continental breakfast, lunch, audiovisual equipment, venue, materials, and other logistics associated with this event. If you need special accommodations due to a disability, please contact Staci McAllister (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04221 Filed 2–26–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–0631] Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ‘‘Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.’’ This guidance describes FDA’s compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading partners engaged in transactions with first responders. This compliance policy is in effect until further notice by FDA. DATES: Effective February 29, 2016. For information about enforcement dates, SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 please see the SUPPLEMENTARY section. ADDRESSES: You may submit comments as follows: INFORMATION 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–D–0631 for ‘‘Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy; Guidance for Industry.’’ 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. E:\FR\FM\29FEN1.SGM 29FEN1

Agencies

[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10259-10260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Medical Devices--Quality Systems Survival: Success Strategies for 
Production and Process Controls/Corrective and Preventative Action; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs, Southwest Regional Office, in co-sponsorship with the FDA 
Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public 
workshop entitled ``Medical Devices--Quality Systems Survival: Success 
Strategies for Production and Process Controls/Corrective and 
Preventative Action''. The public workshop is intended to seek input 
from representatives of medical device manufacturers and other 
stakeholders, on best practices, what has worked for them and what FDA 
can do to inspire

[[Page 10260]]

quality efforts. This event will also focus on various topics of 
interest for those industry representatives who are responsible to 
insure compliance with FDA regulations.

DATES: The meeting will be held on April 15, 2016, from 8 a.m. to 5 
p.m.

ADDRESSES: The meeting will be held at Courtyard and Towne Place Suites 
by Marriott, DFW Airport North/Grapevine, 2200 Bass Pro Ct., Grapevine, 
TX 76051. Directions and lodging information are available at the 
FMDIC, Inc. Web site at http://www.fmdic.org/.

FOR FURTHER INFORMATION CONTACT: Staci McAllister, Consumer Safety 
Technician, Food and Drug Administration, 4040 N. Central Expressway, 
Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, 
staci.mcallister@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The workshop is being held in response to the interest in the 
topics discussed from small medical device manufacturers in the Dallas 
District area. This workshop helps achieve objectives set forth in 
section 406 of the Food and Drug Administration Modernization Act of 
1997 (21 U.S.C. 393), which include working closely with stakeholders 
and maximizing the availability and clarity of information to 
stakeholders and the public. This workshop is also consistent with the 
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 
104-121) as an outreach activity by Government agencies to small 
businesses.
    The goal of the public workshop is to present information that will 
enable manufacturers and regulated industry to better comply with FDA's 
medical device requirements. Please visit the http://www.fmdic.org/ Web 
site for the agenda and for information about the presenters at the 
workshop.

II. Participation in the Public Workshop

    Registration: FMDIC has early registration ($250 for industry/$150 
for government with ID/$50 for students) available until March 14, 
2016. Registration after March 14, 2016, increases to $300 for 
industry, $200 for government with ID, with student registration 
staying the same, at $50. To register online, please visit http://www.fmdic.org/. As an alternative, send the registration information 
including the registrant's name, title, organization, address, 
telephone and fax numbers, and email address (for each registrant), 
along with a check or money order (covering all registration fees) 
payable to the FMDIC, Inc., to FMDIC Registrar, 4447 N. Central 
Expressway, Suite 110 PMB197, Dallas, TX 75205. FMDIC, Inc. accepts 
registrations onsite on the day of the event beginning at 7:30 a.m. at 
the regular registration fee stated above. Registration on site will be 
accepted on a space available basis on the day of the public workshop 
beginning at 7:30 a.m. Please note that due to popularity, similar past 
events have reached maximum capacity well before the day of the event. 
The cost of registration at the site is $300 payable to the FMDIC, Inc. 
The registration fee will be used to offset expenses of hosting the 
event, including continental breakfast, lunch, audiovisual equipment, 
venue, materials, and other logistics associated with this event.
    If you need special accommodations due to a disability, please 
contact Staci McAllister (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance.
    Transcripts: Transcripts of the public workshop will not be 
available due to the format of this workshop.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04221 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P