81 FR 10257 - Agency Information Collection Activities; Proposed Collection; Comment Request; National Direct-to-Consumer Advertising Survey
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 39 (February 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 39 (February 29, 2016)
| Page Range | 10257-10259 | |
| FR Document | 2016-04220 |
[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)] [Notices] [Pages 10257-10259] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04220] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0544] Agency Information Collection Activities; Proposed Collection; 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 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 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 research entitled, ``National Direct-to- Consumer Advertising Survey.'' The objective of this research is to survey the public about their experiences with and attitudes toward direct-to-consumer (DTC) advertising of prescription drugs. DATES: Submit either electronic or written comments on the collection of information by April 29, 2016. 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-0544 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; National Direct-to-Consumer Advertising Survey.'' 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. [[Page 10258]] 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. National Direct-to-Consumer Advertising Survey OMB Control Number 0910--NEW 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 ask 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 nonresponders (Day 12), a paper version of the survey mailed to nonresponders (Day 19), and a reminder postcard sent to nonresponders (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 participants 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 [[Page 10259]] 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 weigh 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. 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. 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. References 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/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: 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
![Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices 10257
information about FDA’s posting of consistent and meaningful tribal public about their experiences with and
comments to public dockets, see 80 FR consultation across FDA Centers and attitudes toward direct-to-consumer
56469, September 18, 2015, or access Offices. (DTC) advertising of prescription drugs.
the information at: http://www.fda.gov/ FDA is announcing the establishment DATES: Submit either electronic or
regulatoryinformation/dockets/ of a docket to receive comments on the written comments on the collection of
default.htm. draft FDA Tribal Consultation Policy. information by April 29, 2016.
Docket: For access to the docket to We invite tribal officials, tribal
read background documents or the organizations, individual tribal Electronic Submissions
electronic and written/paper comments members and other interested persons to Submit electronic comments in the
received, go to http:// comment on the draft FDA Tribal following way:
www.regulations.gov and insert the Consultation Policy. We are interested • Federal eRulemaking Portal: http://
docket number, found in brackets in the in any general comments or concerns www.regulations.gov. Follow the
heading of this document, into the that would help us improve our policy instructions for submitting comments.
‘‘Search’’ box and follow the prompts as well as suggestions on how can we Comments submitted electronically,
and/or go to the Division of Dockets improve our communication and including attachments, to http://
Management, 5630 Fishers Lane, Rm. outreach with Indian Tribes. FDA also www.regulations.gov will be posted to
1061, Rockville, MD 20852. intends to consult with Indian Tribal the docket unchanged. Because your
FOR FURTHER INFORMATION CONTACT:
officials on the draft FDA Tribal comment will be made public, you are
Brian Kehoe, Food and Drug Consultation Policy and summaries of solely responsible for ensuring that your
Administration, 10903 New Hampshire these consultations will be placed in the comment does not include any
Ave., Silver Spring, MD 20993, 301– docket. confidential information that you or a
796–8913. third party may not wish to be posted,
II. Electronic Access
such as medical information, your or
SUPPLEMENTARY INFORMATION: Persons with access to the Internet anyone else’s Social Security number, or
I. Background may obtain the document at either confidential business information, such
http://www.fda.gov/ as a manufacturing process. Please note
Under Executive Order 13175 of ForFederalStateandLocalOfficials/ that if you include your name, contact
November 6, 2000, executive TribalAffairs/default.htm or http:// information, or other information that
departments and Agencies are charged www.regulations.gov. Use the FDA Web identifies you in the body of your
with engaging in regular and meaningful site listed in the previous sentence to comments, that information will be
consultation and collaboration with find the most current version of the posted on http://www.regulations.gov.
tribal officials in the development of document. • If you want to submit a comment
Federal policies that have tribal with confidential information that you
Dated: February 23, 2016.
implications and are responsible for do not wish to be made available to the
strengthening the government-to- Leslie Kux,
Associate Commissioner for Policy. public, submit the comment as a
government relationship between the written/paper submission and in the
United States and Indian tribes. The [FR Doc. 2016–04276 Filed 2–26–16; 8:45 am]
manner detailed (see ‘‘Written/Paper
Department of Health and Human BILLING CODE 4164–01–P
Submissions’’ and ‘‘Instructions’’).
Services (HHS) Tribal Consultation
Policy, revised on December 14, 2010, Written/Paper Submissions
further clarifies that each HHS DEPARTMENT OF HEALTH AND
Submit written/paper submissions as
Operating and Staff Division must have HUMAN SERVICES
follows:
an accountable consultation process to
Food and Drug Administration • Mail/Hand delivery/Courier (for
ensure meaningful and timely input by written/paper submissions): Division of
Tribal officials in the development of [Docket No. FDA–2016–N–0544] Dockets Management (HFA–305), Food
policies that have Tribal implications. and Drug Administration, 5630 Fishers
To date, FDA has followed the HHS Agency Information Collection Lane, Rm. 1061, Rockville, MD 20852.
Tribal Consultation Policy (available at Activities; Proposed Collection; • For written/paper comments
http://www.hhs.gov/about/agencies/iea/ Comment Request; National Direct-to- submitted to the Division of Dockets
tribal-affairs/consultation/index.html). Consumer Advertising Survey Management, FDA will post your
The draft FDA Tribal Consultation AGENCY: Food and Drug Administration, comment, as well as any attachments,
Policy is based on the HHS Tribal HHS. except for information submitted,
Consultation Policy and includes ACTION: Notice. marked and identified, as confidential,
Agency-specific consultation guidelines if submitted as detailed in
that complement the Department-wide SUMMARY: The Food and Drug ‘‘Instructions.’’
efforts. Administration (FDA) is announcing an Instructions: All submissions received
The purpose of the draft FDA Tribal opportunity for public comment on the must include the Docket No. FDA–
Consultation Policy, when finalized, is proposed collection of certain 2016–N–0544 for ‘‘Agency Information
to establish clear policies to further the information by the Agency. Under the Collection Activities; Proposed
government-to-government relationship Paperwork Reduction Act of 1995 (the Collection; Comment Request; National
between FDA and Indian Tribes and PRA), Federal Agencies are required to Direct-to-Consumer Advertising
asabaliauskas on DSK5VPTVN1PROD with NOTICES
facilitate tribal consultation with FDA. publish notice in the Federal Register Survey.’’ Received comments will be
The draft policy provides background concerning each proposed collection of placed in the docket and, except for
on FDA’s mission and organizational information and to allow 60 days for those submitted as ‘‘Confidential
structure and sets out principles and public comment in response to the Submissions,’’ publicly viewable at
guidelines for the tribal consultation notice. This notice solicits comments on http://www.regulations.gov or at the
process. FDA intends for its Tribal research entitled, ‘‘National Direct-to- Division of Dockets Management
Consultation Policy to serve as a Consumer Advertising Survey.’’ The between 9 a.m. and 4 p.m., Monday
platform for the Agency to create objective of this research is to survey the through Friday.
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![Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices 10259
survey, respondents will be randomly characteristics such as demographics, nonresponse. We will examine the
assigned to view one of two ads for insurance coverage, and prescription frequencies for survey items and the
fictional prescription drugs intended to drug use. The survey is available upon relation between survey items and
treat high cholesterol. They will be request. demographic and health characteristics.
asked questions about FDA’s authority We will test for any differences We also plan to compare responses
regarding specific claims within the ad. between modes (online versus mail between this survey and FDA’s 2002
The survey will include a debriefing to survey) and will account for any mode survey for repeated items.
inform respondents that the advertised effects in our analyses. We will weigh
drug was fictitious. We will also the data to account for different FDA estimates the burden of this
measure other potentially important probability of selection and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
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 letter ....................... 81 1 81 .08 (5 min.) .................... 7
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.
References 4. American Association for Public Opinion DEPARTMENT OF HEALTH AND
Research, ‘‘Address-based Sampling’’ HUMAN SERVICES
The following references are on (2016). (http://www.aapor.org/AAPOR_
display in the Division of Dockets Main/media/MainSiteFiles/AAPOR_ Food and Drug Administration
Management (see ADDRESSES) and are Report_1_7_16_CLEAN–COPY–
available for viewing by interested FINAL.pdf). [Docket No. FDA–2016–N–0001]
persons between 9 a.m. and 4 p.m., 5. Millar, M.M. and D.A. Dillman,
Monday through Friday; they are also ‘‘Improving Response to Web and Mixed- Medical Devices—Quality Systems
available electronically at http:// Mode Surveys,’’ Public Opinion Survival: Success Strategies for
www.regulations.gov. FDA has verified Quarterly 1–21 (2011). Production and Process Controls/
the Web site addresses, as of the date 6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and Corrective and Preventative Action;
this document publishes in the Federal S.A. Adlis, ‘‘The Use of Monetary Public Workshop
Register, but Web sites are subject to Incentives in a Community Survey:
AGENCY: Food and Drug Administration,
change over time. Impact on Response Rates, Data Quality,
HHS.
1. Aikin, K.J., J.L. Swasy, and A.C. Braman, and Cost,’’ Health Services Research
35:1339–1346 (2011). ACTION: Notice of public workshop.
‘‘Patient and Physician Attitudes and
Behaviors Associated With DTC 7. Montaquila, J.M., J.M. Brick, D. Williams,
SUMMARY: The Food and Drug
Promotion of Prescription Drugs— K. Kim, et al., ‘‘A Study of Two-Phase
Administration (FDA), Office of
Summary of FDA Survey Research Mail Survey Data Collection Methods,
Results’’ (2004). (http://www.fda.gov/
Regulatory Affairs, Southwest Regional
Journal of Survey Statistics and
downloads/Drugs/ScienceResearch/ Office, in co-sponsorship with the FDA
Methodology 1(1), 66–87 (2013).
ResearchAreas/DrugMarketing Medical Device Industry Coalition, Inc.
AdvertisingandCommunications Dated: February 23, 2016. (FMDIC), is announcing a public
Research/ucm152860.pdf). Leslie Kux, workshop entitled ‘‘Medical Devices—
2. PhRMA Guiding Principles: Direct-to- Quality Systems Survival: Success
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Associate Commissioner for Policy.
Consumer Advertisements About Strategies for Production and Process
[FR Doc. 2016–04220 Filed 2–26–16; 8:45 am]
Prescription Medicines (2008). (http:// Controls/Corrective and Preventative
phrma.org/sites/default/files/pdf/phrma BILLING CODE 4164–01–P
Action’’. The public workshop is
guidingprinciplesdec08final.pdf).
3. Dillman, D.A., J.D. Smyth, and L.M.
intended to seek input from
Christian, Internet, Phone, Mail, and representatives of medical device
Mixed-Mode Surveys: The Tailored manufacturers and other stakeholders,
Design Method, 4th ed. Hoboken, NJ: on best practices, what has worked for
John Wiley & Sons, Inc. (2014). them and what FDA can do to inspire
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Document Created: 2016-02-27 02:05:11
Document Modified: 2016-02-27 02:05:11
| 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 April 29, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 10257 |
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