Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop, 10259-10260 [2016-04221]
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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 https://
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). (https://www.fda.gov/
downloads/Drugs/ScienceResearch/
ResearchAreas/DrugMarketing
AdvertisingandCommunications
Research/ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-toConsumer Advertisements About
Prescription Medicines (2008). (https://
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). (https://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
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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.
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
https://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
https://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 https://
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
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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: 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): 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
https://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]
-----------------------------------------------------------------------
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 https://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 https://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 https://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
