81 FR 51450 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to-Consumer Advertising Survey
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 150 (August 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 150 (August 4, 2016)
| Page Range | 51450-51453 | |
| FR Document | 2016-18425 |
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)] [Notices] [Pages 51450-51453] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18425] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0544] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to- Consumer Advertising Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. [[Page 51451]] DATES: Fax written comments on the collection of information by September 6, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title National Direct-to-Consumer Advertising Survey. Also include the FDA docket number found in brackets in the heading of this document. 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, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. National Direct-to-Consumer Advertising Survey-- OMB Control Number 0910-NEW I. Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(c)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. FDA last surveyed patients about their experiences with and attitudes toward DTC advertising in 2002 (Ref. 1). Numerous changes have affected the DTC landscape since 2002, including declines in print readership, the rise in online prescription drug promotion, and self- imposed industry guidelines for DTC advertising (Ref. 2). These changes may have affected consumers' exposure to different kinds of DTC advertising and its influence on their attitudes and behaviors. The purpose of the National Direct-to-Consumer Advertising Survey is to collect updated insights on consumer experiences with and attitudes towards DTC promotion of prescription drugs. This study will build on previous research by recruiting a wider range of respondents, weighting the data to make it nationally representative, and asking a wider range of questions about DTC promotion, including in online formats. We plan to use an address-based mixed-mode methodology that will direct one randomly-chosen member of sampled households to complete a 20-minute online survey, with non-respondents receiving a paper questionnaire. The sample will be representative of the U.S. population. A sample of U.S. households will be drawn from the U.S. Postal Service Computerized Delivery Sequence File. Adults aged 18 or over will be eligible for participation. Up to five contacts will be sent to respondents by U.S. mail. The contacts will include the URL for the online survey and a unique personal identification number (PIN). This unique PIN will be used to track completed surveys without the use of personally identifying information. The contact method, based on recent recommendations (Ref. 3), includes a notification letter (Day 1), a reminder/thank-you postcard (Day 5), a second letter sent to non- responders (Day 12), a paper version of the survey mailed to non- responders (Day 19), and a reminder postcard sent to non-responders (Day 24). Based on previous research (Refs. 4, 5, and 6), we plan to recruit using two $1 bills ($2 total per sampled respondent) mailed in advance with the initial invitation letter as a gesture to encourage response and maintain data quality. Offering a small token of value to respondents establishes a latent social contract and subsequent reciprocity (Ref. 3). In the second contact attempt, we will conduct an experiment to test whether a short statement mentioning the previously paid incentive increases survey response, thereby testing whether social exchange can be extended past the initial contact attempt. Half the sample will be provided language that reminds them they received a cash incentive in the previous letter; the remaining half will be reminded they received a letter but will not be specifically reminded about the incentive. We estimate a 35 percent response rate, based on recent work on similar studies (Ref. 7). Prior to the main study, a pilot study will be conducted to test the data collection process. We estimate 35 respondents will complete the pilot study and 1,765 will complete the main study (see table 1). The survey contains questions about respondents' knowledge of FDA's authority with respect to prescription drug advertising, their exposure to DTC advertising, their beliefs and attitudes about DTC advertising, and the influence of DTC advertising on further information search and patient-physician interactions. At the end of the 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 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 weight the data to account for different probability of selection and 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. In the Federal Register of February 29, 2016 (81 FR 10257), FDA published a 60-day notice requesting public comment on the proposed collection of information. Nine comments were received. Five comments did not address any of the information collection topics solicited and therefore we do not discuss them in this document (four called for a ban on direct-to-consumer prescription drug advertising and one discussed FDA's response to public comments in general). No comments addressed Topic 2--accuracy of our estimate. Topic 1--practical utility. One comment suggested that we increase the practical utility of the survey by (1) including teenagers 14-18 years of age, and (2) skewing the survey to include a disproportionate number of Americans over 50 years of age. Another comment suggested we use a quota to ensure that limited literacy respondents are included. One of our main goals is to survey a nationally representative sample of U.S. adults about their experiences with and attitudes towards DTC promotion of prescription drugs. Note that we have designed other studies that specifically examine adolescent and older adults' responses to prescription drug advertising (FDA-2013-N-1151-0004, ``Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents''; FDA-2015-N-2163-000, ``Hearing, Aging, and Direct-to- Consumer Television Advertisements''). We will measure health literacy within the survey. One comment suggested that respondents should watch a [[Page 51452]] prescription drug television ad and then answer questions about benefit and risk recall. Although this design is beyond what we can accomplish within a nationally representative survey, we have conducted studies that use this design (for examples, see http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm). Topic 3--ways to enhance quality, clarity, utility. Four comments suggested changes to the survey to enhance its quality, clarity, and utility. Three comments suggested changing our terminology throughout the survey for clarity. As suggested, we changed ``television'' to ``TV,'' ``advertisement'' to ``ad,'' used ``health care provider'' throughout the survey, and specified that by Internet we mean Internet accessed by computer, phone, or tablet. We changed ``small print'' to ``additional information.'' We did not change ``prescription drug'' to ``medicine.'' Respondents in cognitive interviews understood the term ``prescription drug,'' and we are concerned that ``medicine'' is too broad. We also chose not to highlight or bold ``prescription drug'' as cognitive interview respondents understood the purpose of the survey and we do not want to overuse highlighting. Also, two comments suggested deleting survey questions. Two comments questioned the utility of a series of questions about the safety and efficacy of certain products. We agree that these questions are not as central to the survey topic and have deleted them. They also recommended deleting a series of questions about FDA approval of DTC promotion. These questions will highlight claims within the ad to determine whether consumers believe that advertising in general as well as specific claims are approved by FDA. Therefore, we have chosen to keep these questions on the survey. One comment recommended deleting a question perceived to be too negative whereas another comment recommended adding positive answer choices to balance the question; we chose the latter option. In addition, four comments suggested additional topics for survey questions. In response we added questions about whether prescription drug advertising has caused respondents to talk with their healthcare provider about symptoms or side effects they've experienced, or to look for information about a prescription drug they thought might be helpful for a friend of family member. We also added a question about the respondents' primary language. Finally, we now ask whether respondents have seen prescription drug promotion on streaming services and whether they have looked for information on medical association Web sites. One comment suggested adding places where consumers could see or hear advertisements (e.g., ``on television at the doctor's office,'' ``in a pharmacy'') to a question that asks about the type of medium where they saw or heard an ad (e.g., ``TV,'' ``print''). We chose not to take this suggestion because the question concerns medium, not location. We are also concerned about measurement error. For instance, some doctor's offices have magazines with DTC print ads, TVs playing broadcast television, or TVs playing videos. This also relies on having gone to a doctor or pharmacist in the last 3 months. One comment suggested adding additional response options to a question about where consumers might attain more information about prescription drugs. Because this question is focused on adequate provision in DTC television ads, we chose not to add any additional response options beyond those specific to adequate provision (i.e., branded Web site, manufacturer's toll-free number, print ad, and health care provider). We note that the survey contains a series of questions about various new media, including social media, Web sites, and online videos. It also asks about respondents' attitudes about how benefits and risks are presented, whether they have seen information about the medical condition in TV ads, and whether they've looked for information on government Web sites. We chose not to ask whether they've looked for information on manufacturer Web sites because we don't want respondents to confuse it with the option, ``a prescription drug Web site.'' Finally, three comments had suggestions for how we ask our questions. One comment recommended reducing or eliminating the number of open-ended questions. The main survey has only two questions with an open-ended option (allowing respondents to specify another response). If pilot testing reveals potential closed-ended response options for these two questions we will add them to the main survey. One comment suggested changing our scale for how we measure exposure to prescription drug promotion. We changed this scale from qualitative frequency to a yes/no scale. Similarly, one comment asked us to consider how we measure how much of an ad respondents saw or read because there may be many variables that affect this. We have chosen not to change this scale but will consider this point when interpreting the data. One comment suggested that we randomize response order for the paper-based surveys. We plan to create multiple versions of the paper-based scale to account for household sampling and viewing of the ad, so we are concerned that creating different versions to account for response option randomization will be too complex for a survey of this scale. However, we agree that response option order is important to take into account when interpreting results. Topic 4--ways to minimize burden. One comment suggested we conduct the survey with an online consumer survey panel to reduce time and costs and increase response rates. Although we agree that online survey panels can be an efficient way to collect data, this survey is designed to be nationally representative. Following OMB's advice, therefore, we will use the Internet as one mode of data collection but will not rely on an online survey panel for sampling (https://www.whitehouse.gov/sites/default/files/omb/inforeg/pmc_survey_guidance_2006.pdf). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Pilot Study ---------------------------------------------------------------------------------------------------------------- Survey invitation letter........ 100 1 100 .08 (5 min.) 8 Reminder postcard............... 100 1 100 .03 (2 min.) 3 Non-response letter............. 82 1 82 .08 (5 min.) 7 Non-response questionnaire 81 1 81 .08 (5 min.) 7 letter......................... [[Page 51453]] Second postcard................. 60 1 60 .03 (2 min.) 2 Survey.......................... 35 1 35 .33 (20 min.) 12 ---------------------------------------------------------------------------------------------------------------- Main Study ---------------------------------------------------------------------------------------------------------------- Survey invitation letter........ 5,042 1 5,042 .08 (5 min.) 403 Reminder postcard............... 5,042 1 5,042 .03 (2 min.) 151 Non-response letter............. 4,173 1 4,173 .08 (5 min.) 334 Non-response questionnaire 4,073 1 4,073 .08 (5 min.) 326 letter......................... Second postcard................. 3,063 1 3,063 .03 (2 min.) 92 Survey.......................... 1,765 1 1,765 .33 (20 min.) 582 --------------- Total....................... .............. .............. .............. .............. 1927 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. II. References The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 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/DrugMarketingAdvertisingandCommunicationsResearch/ucm152860.pdf). 2. PhRMA Guiding Principles: Direct-to-Consumer Advertisements About Prescription Medicines 2008. (http://phrma.org/sites/default/files/pdf/phrmaguidingprinciplesdec08final.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. 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 Mixed-Mode 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: July 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18425 Filed 8-3-16; 8:45 am] BILLING CODE 4164-01-P
![51450 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
and Drug Administration, 5630 Fishers Submit written requests for single these facilities and potential problems
Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the with their drug products, or conditions
• For written/paper comments Division of Drug Information, Center for and practices, unless it receives a
submitted to the Division of Dockets Drug Evaluation and Research, Food complaint such as a report of a serious
Management, FDA will post your and Drug Administration, 10001 New adverse event or visible contamination.
comment, as well as any attachments, Hampshire Ave., Hillandale Building, It is critical that compounding facilities
except for information submitted, 4th Floor, Silver Spring, MD 20993– avoid the presence of insanitary
marked and identified, as confidential, 0002. Send one self-addressed adhesive conditions and identify and remediate
if submitted as detailed in label to assist that office in processing any insanitary conditions at their
‘‘Instructions.’’ your requests. See the SUPPLEMENTARY facilities before the conditions result in
Instructions: All submissions received INFORMATION section for electronic drug contamination and patient injury.
must include the Docket No. FDA– access to the draft guidance document. FDA is issuing this draft guidance to
2016–D–2268 for ‘‘Insanitary Conditions FOR FURTHER INFORMATION CONTACT: Sara assist compounding facilities in
at Compounding Facilities.’’ Received Rothman, Center for Drug Evaluation identifying insanitary conditions so that
comments will be placed in the docket they can implement appropriate
and Research, Food and Drug
and, except for those submitted as corrective actions, and to assist State
Administration, 10903 New Hampshire
‘‘Confidential Submissions,’’ publicly regulatory agencies in understanding
Ave., Bldg. 51, Rm. 5197, Silver Spring,
viewable at http://www.regulations.gov some examples of what FDA considers
MD 20993, 301–796–3110.
or at the Division of Dockets to be insanitary conditions.
Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: This draft guidance is being issued
Monday through Friday. I. Background consistent with FDA’s good guidance
• Confidential Submissions—To practices regulation (21 CFR 10.115).
submit a comment with confidential FDA is announcing the availability of
The draft guidance, when finalized, will
information that you do not wish to be a draft guidance for industry entitled
represent the current thinking of FDA
made publicly available, submit your ‘‘Insanitary Conditions at Compounding
on insanitary conditions at
comments only as a written/paper Facilities.’’ Under section 501(a)(2)(A)
compounding facilities. It does not
submission. You should submit two of the Federal Food, Drug, and Cosmetic
establish any rights for any person and
copies total. One copy will include the Act (the FD&C Act) (21 U.S.C.
is not binding on FDA or the public.
information you claim to be confidential 351(a)(2)(A)), a drug is deemed to be
You can use an alternative approach if
with a heading or cover note that states adulterated if it has been prepared,
it satisfies the requirements of the
‘‘THIS DOCUMENT CONTAINS packed, or held under insanitary
applicable statutes and regulations.
CONFIDENTIAL INFORMATION.’’ The conditions whereby it may have been
Agency will review this copy, including contaminated with filth, or whereby it II. Electronic Access
the claimed confidential information, in may have been rendered injurious to Persons with access to the Internet
its consideration of comments. The health. Drug products compounded may obtain the draft guidance at either
second copy, which will have the under insanitary conditions could http://www.fda.gov/Drugs/Guidance
claimed confidential information become contaminated and cause serious ComplianceRegulatoryInformation/
redacted/blacked out, will be available adverse events in patients, including Guidances/default.htm or http://
for public viewing and posted on http:// death. Although sections 503A and www.regulations.gov.
www.regulations.gov. Submit both 503B of the FD&C Act (21 U.S.C. 353a
Dated: July 29, 2016.
copies to the Division of Dockets and 353b) provide exemptions for
compounded drugs from specified Leslie Kux,
Management. If you do not wish your
provisions of the FD&C Act if certain Associate Commissioner for Policy.
name and contact information to be
made publicly available, you can conditions are met, neither section [FR Doc. 2016–18461 Filed 8–3–16; 8:45 am]
provide this information on the cover provides an exemption from section BILLING CODE 4164–01–P
sheet and not in the body of your 501(a)(2)(A) of the FD&C Act. Any drug
comments and you must identify this that is prepared, packed, or held under
information as ‘‘confidential.’’ Any insanitary conditions is deemed to be DEPARTMENT OF HEALTH AND
information marked as ‘‘confidential’’ adulterated under the FD&C Act, HUMAN SERVICES
will not be disclosed except in including drugs produced by a
Food and Drug Administration
accordance with 21 CFR 10.20 and other compounding facility.
applicable disclosure law. For more Since the 2012 fungal meningitis [Docket No. FDA–2016–N–0544]
information about FDA’s posting of outbreak associated with injectable drug
comments to public dockets, see 80 FR products that a compounding facility Agency Information Collection
56469, September 18, 2015, or access produced and shipped across the Activities; Submission for Office of
the information at: http://www.fda.gov/ country, FDA has identified insanitary Management and Budget Review;
regulatoryinformation/dockets/ conditions at many of the compounding Comment Request; National Direct-to-
default.htm. facilities that it has inspected, and Consumer Advertising Survey
Docket: For access to the docket to numerous compounding facilities have AGENCY: Food and Drug Administration,
read background documents or the voluntarily recalled drug products HHS.
electronic and written/paper comments intended to be sterile and temporarily or ACTION: Notice.
received, go to http:// permanently ceased sterile operations as
sradovich on DSK3GMQ082PROD with NOTICES
www.regulations.gov and insert the a result of these findings. However, FDA SUMMARY: The Food and Drug
docket number, found in brackets in the does not inspect the vast majority of Administration (FDA) is announcing
heading of this document, into the compounding facilities in the United that a proposed collection of
‘‘Search’’ box and follow the prompts States because they generally do not information has been submitted to the
and/or go to the Division of Dockets register with FDA unless they elect to Office of Management and Budget
Management, 5630 Fishers Lane, Rm. become outsourcing facilities. (OMB) for review and clearance under
1061, Rockville, MD 20852. Therefore, FDA is often not aware of the Paperwork Reduction Act of 1995.
VerDate Sep<11>2014 18:12 Aug 03, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1](https://thefederalregister.org/doc/81_FR_51600/page/1.svg)
![Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices 51453
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Second postcard .................................................................. 60 1 60 .03 (2 min.) 2
Survey .................................................................................. 35 1 35 .33 (20 min.) 12
Main Study
Survey invitation letter ......................................................... 5,042 1 5,042 .08 (5 min.) 403
Reminder postcard ............................................................... 5,042 1 5,042 .03 (2 min.) 151
Non-response letter ............................................................. 4,173 1 4,173 .08 (5 min.) 334
Non-response questionnaire letter ....................................... 4,073 1 4,073 .08 (5 min.) 326
Second postcard .................................................................. 3,063 1 3,063 .03 (2 min.) 92
Survey .................................................................................. 1,765 1 1,765 .33 (20 min.) 582
Total .............................................................................. ........................ ........................ ........................ ........................ 1927
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References Journal of Survey Statistics and Methodology and Supplement Facts Label and
1(1), 66–87. 2013. Reference Amounts Customarily
The following references are on
display in the Division of Dockets Dated: July 29, 2016. Consumed Per Eating Occasion’’ to
Management (HFA–305), Food and Drug Leslie Kux, OMB for review and clearance under 44
Administration, 5630 Fishers Lane, Rm. Associate Commissioner for Policy. U.S.C. 3507. An Agency may not
1061, Rockville, MD 20852 and are [FR Doc. 2016–18425 Filed 8–3–16; 8:45 am]
conduct or sponsor, and a person is not
available for viewing by interested required to respond to, a collection of
BILLING CODE 4164–01–P
persons between 9 a.m. and 4 p.m., information unless it displays a
Monday through Friday; they are also currently valid OMB control number.
available electronically at http:// DEPARTMENT OF HEALTH AND OMB has now approved the information
www.regulations.gov. FDA has verified HUMAN SERVICES collection and has assigned OMB
the Web site addresses, as of the date control number 0910–0813. The
this document publishes in the Federal Food and Drug Administration approval expires on July 31, 2019. A
Register, but Web sites are subject to copy of the supporting statement for this
[Docket Nos. FDA–2012–N–1210; FDA–
change over time. information collection is available on
2004–N–0258]
the Internet at http://www.reginfo.gov/
1. Aikin, K.J., J.L. Swasy, and A.C. Braman, public/do/PRAMain.
‘‘Patient and Physician Attitudes and Agency Information Collection
Behaviors Associated With DTC Promotion of Activities; Announcement of Office of Dated: August 1, 2016.
Prescription Drugs—Summary of FDA Management and Budget Approval; Leslie Kux,
Survey Research Results,’’ 2004. (http:// Food Labeling: Nutrition Facts and Associate Commissioner for Policy.
www.fda.gov/downloads/Drugs/Science Supplement Facts Label and Reference [FR Doc. 2016–18509 Filed 8–3–16; 8:45 am]
Research/ResearchAreas/DrugMarketing Amounts Customarily Consumed per
AdvertisingandCommunicationsResearch/ BILLING CODE 4164–01–P
Eating Occasion
ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-to- AGENCY: Food and Drug Administration,
Consumer Advertisements About HHS. DEPARTMENT OF HEALTH AND
Prescription Medicines 2008. (http:// HUMAN SERVICES
phrma.org/sites/default/files/pdf/ ACTION: Notice.
phrmaguidingprinciplesdec08final.pdf). Food and Drug Administration
3. Dillman, D.A., J.D. Smyth, and L.M.
SUMMARY: The Food and Drug
Christian, Internet, Phone, Mail, and Mixed- Administration (FDA) is announcing [Docket Nos. FDA–2016–M–1122, FDA–
Mode Surveys: The Tailored Design Method, that a collection of information entitled 2016–M–1123, FDA–2016–M–1124, FDA–
4th ed. Hoboken, NJ: John Wiley & Sons, Inc., ‘‘Food Labeling: Nutrition Facts and 2016–M–1125, FDA–2016–M–1165, FDA–
2014. Supplement Facts Label and Reference 2016–M–1166, FDA–2016–M–1167, FDA–
4. American Association for Public Amounts Customarily Consumed Per 2016–M–1168, FDA–2016–M–1222, FDA–
Opinion Research, ‘‘Address-based 2016–M–1223, FDA–2016–M–1400, FDA–
Eating Occasion’’ has been approved by 2016–M–1401, FDA–2016–M–1455, FDA–
Sampling,’’ 2016. (http://www.aapor.org/ the Office of Management and Budget
AAPOR_Main/media/MainSiteFiles/AAPOR_ 2016–M–1459, FDA–2016–M–1754, and
(OMB) under the Paperwork Reduction FDA–2016–M–1755]
Report_1_7_16_CLEAN-COPY-FINAL.pdf).
5. Millar, M.M. and D.A. Dillman,
Act of 1995.
‘‘Improving Response to Web and Mixed- FOR FURTHER INFORMATION CONTACT: FDA Medical Devices; Availability of Safety
Mode Surveys,’’ Public Opinion Quarterly 1– PRA Staff, Office of Operations, Food and Effectiveness Summaries for
21. 2011. and Drug Administration, Three White Premarket Approval Applications
sradovich on DSK3GMQ082PROD with NOTICES
6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and Flint North 10A–12M, 11601
S.A. Adlis, ‘‘The Use of Monetary Incentives AGENCY: Food and Drug Administration,
Landsdown St., North Bethesda, MD HHS.
in a Community Survey: Impact on Response 20852, PRAStaff@fda.hhs.gov.
Rates, Data Quality, and Cost,’’ Health ACTION: Notice.
Services Research 35:1339–1346. 2011. SUPPLEMENTARY INFORMATION: On May
7. Montaquila, J.M., J.M. Brick, D. 27, 2016, the Agency submitted a SUMMARY: The Food and Drug
Williams, K. Kim, et al., ‘‘A Study of Two- proposed collection of information Administration (FDA) is publishing a
Phase Mail Survey Data Collection Methods,’’ entitled ‘‘Food Labeling: Nutrition Facts list of premarket approval applications
VerDate Sep<11>2014 18:12 Aug 03, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1](https://thefederalregister.org/doc/81_FR_51600/page/4.svg)
Document Created: 2016-08-04 02:53:15
Document Modified: 2016-08-04 02:53:15
| 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 | Fax written comments on the collection of information by September 6, 2016. | |
| 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 51450 |
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