81 FR 5470 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 21 (February 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 21 (February 2, 2016)
| Page Range | 5470-5472 | |
| FR Document | 2016-01788 |
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)] [Notices] [Pages 5470-5472] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01788] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1855] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products 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. DATES: Fax written comments on the collection of information by March 3, 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 [email protected]. All comments should be identified with the OMB control number 0910-NEW and title ``Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products.'' 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products OMB Control Number 0910-NEW FDA's Center for Tobacco Products proposes to conduct experimental studies to develop generalizable scientific knowledge to help inform its implementation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating information submitted to the Agency about how consumers understand and perceive tobacco products marketed as modified risk tobacco products (MRTPs). Section 911 of the FD&C Act authorizes FDA to grant orders to persons to allow the marketing of MRTPs. The term ``modified risk tobacco product'' means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco- related disease associated with commercially marketed tobacco products. FDA must issue an order authorizing the marketing of an MRTP if the Agency determines that the product, as it is actually used by consumers, will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(1) of the FD&C Act). FDA may also issue an order authorizing the marketing of an MRTP that reduces or eliminates exposure to a harmful substance if, among other requirements, the Agency determines that the order would be appropriate to promote the public health, the issuance of the order is expected to benefit the population as a whole taking into account both users and nonusers of tobacco products, and the existing evidence demonstrates that a measurable and substantial reduction in morbidity and mortality among individual tobacco users is reasonably likely to be shown in subsequent studies (section 911(g)(2) of the FD&C Act). In addition, section 911 requires that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health related conditions associated with the use of tobacco products (section 911(h)(1) of the FD&C Act). The proposed research will inform the Agency's efforts to implement the provisions of the FD&C Act related to MRTPs. FDA proposes to conduct experimental studies in order to develop generalizable scientific information to better understand how consumers perceive and understand these products, how exposure to claims about modified risk or exposure influence intentions to try or purchase the product, and how individual characteristics such as current tobacco use and/or brand loyalty might influence these outcomes. Moreover, information from the experimental studies may assist FDA to determine the appropriate methods and [[Page 5471]] measures for gathering such information from consumers. The impact of different claims pertaining to modified risk or exposure on understanding, perceptions, and use intentions will be evaluated by conducting a series of three studies that, in turn, will examine: The impact of claims about cigarette (Study 1) or smokeless tobacco products (Study 2) among young adult and adult current, former, or never users of tobacco; and the impact of claims on adolescents currently using, or susceptible to using, tobacco (Study 3). All three studies will assess individual-level factors that might influence the impact of claims on consumer responses, including: Brand loyalty, tobacco use history and behavior, concerns about health risks, and openness to new products. Across all studies, participants will be randomized to either see modified risk claims or not (control condition). In Studies 1 and 2, modified risk claims will be displayed on mock tobacco product packages and ads. For ethical reasons, adolescents (Study 3) will see modified risk claims displayed as statements alone, not attached to product packaging or ads. Consumer reactions to claims will be evaluated by measuring constructs such as: Understanding of the modified risk information in the claims, perceptions of harm and risk, beliefs about the product, quit intentions, and intention to try or purchase the product. In the Federal Register of November 19, 2014 (79 FR 68888), FDA published a 60-day notice requesting public comment on the proposed collection of information. Three comments were received, however only two were PRA related. (Comment) One commenter critiqued the inclusion of items assessing brand loyalty, asserting such constructs have ``no practical utility'' for MRTPA review and is beyond the FDA's statutory authority because it is not mentioned in the FD&C Act. (Response) FDA does not agree. Although concepts such as ``brand loyalty'' are not specifically mentioned in the FD&C Act, FDA seeks understanding of how attitudes toward one's preferred brand(s) may affect perceptions and understanding of modified risk information (section 911(h)(1)). The goal of the present experiments is to understand how consumers react to RM and EM claims, in order to inform FDA's ability to evaluate MRTPAs. Brand loyalty is widely regarded as an important driver of consumer behavior (Ref. 1). Moreover, psychological theory and evidence suggests that the source of information can affect how that information is processed--including whether or not it is perceived as believable and is persuasive (Ref. 2). Thus, consumers' brand attitudes are highly relevant to understanding how they interpret and respond to claims made by that brand. To omit this possible influence from our analyses would, in our assessment, limit our ability to fully understand consumer perceptions of MRTPs. (Comment) One commenter suggested that to assess the variable ``purchase interest,'' FDA should assign a hypothetical price to the product being studied. (Response) FDA acknowledges that price plays an important role in consumers' purchasing decisions. However, examination of the role of price is beyond the scope of the present studies. The experimental design of this study will enable comparisons between experimental conditions on intentions to use the product; thus, rather than evaluating absolute levels of interest, results will examine relative levels of interest across experimental conditions. Thus, the measure of intentions to use the product will assess consumer interest in the product without regard to cost. (Comment) One commenter noted that Study 1 proposes to focus on conventional cigarettes and asks how FDA proposes to address the issue of novel devices/products when considering consumer perceptions? (Response) FDA agrees that the current studies are not designed to assess interest in novel devices/products. Addressing questions related to consumer perceptions of novel devices/products, and reactions to claims about those products, is beyond the scope of the current set of studies. (Comment) One commenter asked for specificity regarding how FDA will define susceptibility to tobacco use among the adolescents in Study 3. (Response) FDA plans to use items from Pierce and colleagues (1996) to identify adolescents who are susceptible to using tobacco. These items are: (1) Do you think that you will smoke a cigarette soon? (2) Do you think you will smoke a cigarette at any time in the next year? and (3) If one of your best friends were to offer you a cigarette, would you smoke it? Response options are: (1) Definitely yes; (2) Probably yes; (3) Probably not; and (4) Definitely not. A respondent who selects a response of 1, 2, or 3 to any of these items is classified as susceptible. (Comment) One commenter sought clarification regarding which health warnings will be used (on the study stimuli) alongside the claims and how FDA intends to address the balance between MRTP claims and warnings. (Response) Study stimuli-images of tobacco product packages and ads-will display the warning labels currently mandated for each product category. The warnings will be rotated (between participants) so that all mandated warnings are used. Because the current studies are not intended to examine the relationship between warnings and claims (including potential interactions between the two), warning label assignment will not be an experimental factor in the study design. Instead, the warnings will be rotated throughout all conditions to control for any differences between them (alone or in combination with a particular claim). 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 per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Adult Screener............................... 24,000 1 24,000 0.03 (2 minutes)......................... 720 Study 1 (Adults)............................. 1,800 1 1,800 0.333 (20 minutes)....................... 599 Study 2 (Adults)............................. 600 1 600 0.333 (20 minutes)....................... 200 ------------------------------------------------ --------------- Total Adult Hours........................ .............. .............. .............. ......................................... 1,519 Youth Screener............................... 6,000 1 6,000 0.03 (2 minutes)......................... 180 ------------------------------------------------ --------------- Study 3 (Youth).............................. 600 1 600 0.333 (20 minutes)....................... 200 ------------------------------------------------ --------------- [[Page 5472]] Total Youth Hours........................ .............. .............. .............. ......................................... 380 ------------------------------------------------ --------------- Total Hours.......................... .............. .............. .............. ......................................... 1,899 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on prior experience with research that is similar to this proposed study. Approximately 30,000 respondents will complete a screener to determine eligibility for participation in a study, estimated to take approximately 2 minutes (0.03 hours), for a total of 900 hours for screening activities. Three thousand respondents will complete a full study, estimated to last 20 minutes (0.333 hours), for a total of 999 hours for completion of both adult studies and 1 youth study. The estimated total hour burden of the collection of information is 1,899 hours. 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. 1. Keller, Kevin L. and Donald R. Lehman, ``Brands and Branding: Research Findings and Future Priorities,'' Marketing Science, vol. 25, no. 6, pp. 740-759, 2006. 2. Eagly, Alice H. and Shelly Chaiken, ``Process Theories of Attitude Formation and Change: Reception and Cognitive Responding,'' The Psychology of Attitudes, Chapter 6, Harcourt Brace Jovanovich College Publishers, 1993. Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01788 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
![5470 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND tobacco products marketed as modified
HUMAN SERVICES HUMAN SERVICES risk tobacco products (MRTPs). Section
911 of the FD&C Act authorizes FDA to
Food and Drug Administration Food and Drug Administration grant orders to persons to allow the
[Docket No. FDA–2014–N–1855] marketing of MRTPs. The term
[Docket No. FDA–2000–D–0075] ‘‘modified risk tobacco product’’ means
Agency Information Collection any tobacco product that is sold or
Agency Information Collection Activities; Submission for Office of distributed for use to reduce harm or the
Activities; Announcement of Office of Management and Budget Review; risk of tobacco-related disease
Management and Budget Approval; Comment Request; Experimental associated with commercially marketed
Voluntary Labeling Indicating Whether Studies on Consumer Perceptions of tobacco products. FDA must issue an
Foods Have or Have Not Been Derived Modified Risk Tobacco Products order authorizing the marketing of an
From Genetically Engineered Plants MRTP if the Agency determines that the
AGENCY: Food and Drug Administration, product, as it is actually used by
HHS. consumers, will significantly reduce
AGENCY: Food and Drug Administration,
ACTION: Notice. harm and the risk of tobacco-related
HHS.
disease to individual tobacco users and
ACTION: Notice. SUMMARY: The Food and Drug
benefit the health of the population as
Administration (FDA) is announcing
a whole taking into account both users
that a proposed collection of
SUMMARY: The Food and Drug of tobacco products and persons who do
information has been submitted to the
Administration (FDA) is announcing not currently use tobacco products
Office of Management and Budget
that a collection of information entitled (section 911(g)(1) of the FD&C Act).
(OMB) for review and clearance under
‘‘Voluntary Labeling Indicating Whether the Paperwork Reduction Act of 1995. FDA may also issue an order
Foods Have or Have Not Been Derived authorizing the marketing of an MRTP
DATES: Fax written comments on the
From Genetically Engineered Plants’’ that reduces or eliminates exposure to a
collection of information by March 3,
has been approved by the Office of harmful substance if, among other
2016.
Management and Budget (OMB) under requirements, the Agency determines
the Paperwork Reduction Act of 1995. ADDRESSES: To ensure that comments on that the order would be appropriate to
the information collection are received, promote the public health, the issuance
FOR FURTHER INFORMATION CONTACT: FDA OMB recommends that written of the order is expected to benefit the
PRA Staff, Office of Operations, Food comments be faxed to the Office of population as a whole taking into
and Drug Administration, 8455 Information and Regulatory Affairs, account both users and nonusers of
Colesville Rd., COLE–14526, Silver OMB, Attn: FDA Desk Officer, FAX: tobacco products, and the existing
Spring, MD 20993–0002, PRAStaff@ 202–395–7285, or emailed to oira_ evidence demonstrates that a
fda.hhs.gov. submission@omb.eop.gov. All measurable and substantial reduction in
comments should be identified with the morbidity and mortality among
SUPPLEMENTARY INFORMATION: On OMB control number 0910–NEW and individual tobacco users is reasonably
December 9, 2015, the Agency title ‘‘Experimental Studies on likely to be shown in subsequent studies
submitted a proposed collection of Consumer Perceptions of Modified Risk (section 911(g)(2) of the FD&C Act). In
information entitled ‘‘Voluntary Tobacco Products.’’ Also include the addition, section 911 requires that any
Labeling Indicating Whether Foods FDA docket number found in brackets advertising or labeling concerning
Have or Have Not Been Derived From in the heading of this document. modified risk products enable the
Genetically Engineered Plants’’ to OMB FOR FURTHER INFORMATION CONTACT: FDA public to comprehend the information
for review and clearance under 44 PRA Staff, Office of Operations, Food concerning modified risk and to
U.S.C. 3507. An Agency may not and Drug Administration, 8455 understand the relative significance of
conduct or sponsor, and a person is not Colesville Rd., COLE–14526, Silver such information in the context of total
required to respond to, a collection of Spring, MD 20993–0002, PRAStaff@ health and in relation to all of the
information unless it displays a fda.hhs.gov. diseases and health related conditions
currently valid OMB control number. SUPPLEMENTARY INFORMATION: In associated with the use of tobacco
OMB has now approved the information compliance with 44 U.S.C. 3507, FDA products (section 911(h)(1) of the FD&C
collection and has assigned OMB has submitted the following proposed Act). The proposed research will inform
control number 0910–0807. The collection of information to OMB for the Agency’s efforts to implement the
approval expires on January 31, 2019. A review and clearance. provisions of the FD&C Act related to
copy of the supporting statement for this MRTPs.
Experimental Studies on Consumer FDA proposes to conduct
information collection is available on Perceptions of Modified Risk Tobacco
the Internet at http://www.reginfo.gov/ experimental studies in order to develop
Products OMB Control Number 0910– generalizable scientific information to
public/do/PRAMain. NEW better understand how consumers
Dated: January 25, 2016. FDA’s Center for Tobacco Products perceive and understand these products,
Leslie Kux, proposes to conduct experimental how exposure to claims about modified
Associate Commissioner for Policy. studies to develop generalizable risk or exposure influence intentions to
wgreen on DSK2VPTVN1PROD with NOTICES
[FR Doc. 2016–01786 Filed 2–1–16; 8:45 am] scientific knowledge to help inform its try or purchase the product, and how
BILLING CODE 4164–01–P
implementation of section 911 of the individual characteristics such as
Federal Food, Drug, and Cosmetic Act current tobacco use and/or brand loyalty
(FD&C Act) (21 U.S.C. 387k), wherein might influence these outcomes.
FDA will be evaluating information Moreover, information from the
submitted to the Agency about how experimental studies may assist FDA to
consumers understand and perceive determine the appropriate methods and
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![5472 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices
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
Total Youth Hours .............................................. ........................ ........................ ........................ .................................. 380
Total Hours .................................................. ........................ ........................ ........................ .................................. 1,899
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on provisions set forth in sections Tumor Progression and Metastasis Study
prior experience with research that is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Section.
similar to this proposed study. as amended. The grant applications and Date: March 2–3, 2016.
Approximately 30,000 respondents will the discussions could disclose Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
complete a screener to determine confidential trade secrets or commercial applications.
eligibility for participation in a study, property such as patentable material, Place: Embassy Suites at the Chevy Chase
estimated to take approximately 2 and personal information concerning Pavilion, 4300 Military Road NW.,
minutes (0.03 hours), for a total of 900 individuals associated with the grant Washington, DC 20015.
hours for screening activities. Three applications, the disclosure of which Contact Person: Rolf Jakobi, Ph.D.,
thousand respondents will complete a would constitute a clearly unwarranted Scientific Review Officer, Center for
full study, estimated to last 20 minutes invasion of personal privacy. Scientific Review, National Institutes of
(0.333 hours), for a total of 999 hours for Health, 6701 Rockledge Drive, Room 6187,
Name of Committee: Center for Scientific
completion of both adult studies and 1 MSC 7806, Bethesda, MD 20892, 301–495–
Review Special Emphasis Panel, Member
youth study. The estimated total hour 1718; jakobir@mail.nih.gov.
Conflict: Medical Imaging Investigations.
burden of the collection of information Date: February 18, 2016. Name of Committee: Center for Scientific
is 1,899 hours. Time: 8:00 a.m. to 5:00 p.m. Review Special Emphasis Panel, Member
Agenda: To review and evaluate grant Conflict: Alcohol, Drugs and
References applications. Neurotoxicology.
Place: National Institutes of Health, 6701 Date: March 2–3, 2016.
The following references are on
Rockledge Drive, Bethesda, MD 20892 Time: 8:00 a.m. to 12:00 p.m.
display in the Division of Dockets (Virtual Meeting). Agenda: To review and evaluate grant
Management (see ADDRESSES) and are Contact Person: Mehrdad Mohseni, MD, applications.
available for viewing by interested Scientific Review Officer, Center for Place: National Institutes of Health, 6701
persons between 9 a.m. and 4 p.m., Scientific Review, National Institutes of Rockledge Drive, Bethesda, MD 20892
Monday through Friday; they are also Health, 6701 Rockledge Drive, Room 5211, (Virtual Meeting).
available electronically at http:// MSC 7854, Bethesda, MD 20892, 301–435– Contact Person: Michael Selmanoff, Ph.D.,
www.regulations.gov. 0484; mohsenim@csr.nih.gov. Scientific Review Officer, Center for
Name of Committee: Brain Disorders and Scientific Review, National Institutes of
1. Keller, Kevin L. and Donald R. Lehman, Clinical Neuroscience Integrated Review Health, 6701 Rockledge Drive, Room 5164,
‘‘Brands and Branding: Research Group, Diseases and Pathophysiology of the MSC 7844, Bethesda, MD 20892, 301–435–
Findings and Future Priorities,’’ Visual System Study Section. 1119; selmanom@csr.nih.gov.
Marketing Science, vol. 25, no. 6, pp. Date: February 25–26, 2016. Name of Committee: Center for Scientific
740–759, 2006. Time: 8:00 a.m. to 5:00 p.m. Review Special Emphasis Panel, PAR–13–
2. Eagly, Alice H. and Shelly Chaiken, Agenda: To review and evaluate grant 327: Innovative Molecular Analysis
‘‘Process Theories of Attitude Formation applications. Technology Development for Cancer
and Change: Reception and Cognitive Place: Bahia Resort Hotel, 998 West Research and Clinical Care.
Responding,’’ The Psychology of Mission Bay Drive, San Diego, CA 92109. Date: March 2, 2016.
Attitudes, Chapter 6, Harcourt Brace Contact Person: Nataliya Gordiyenko, Time: 11:00 a.m. to 5:00 p.m.
Jovanovich College Publishers, 1993. Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant
Scientific Review, National Institutes of applications.
Dated: January 27, 2016. Health, 6701 Rockledge Drive, Room 5202,
Leslie Kux, Place: National Institutes of Health, 6701
MSC 7846, Bethesda, MD 20892, 301–435–
Rockledge Drive, Bethesda, MD 20892.
Associate Commissioner for Policy. 1265; gordiyenkon@csr.nih.gov.
Contact Person: Zhang-Zhi Hu, MD,
[FR Doc. 2016–01788 Filed 2–1–16; 8:45 am] Name of Committee: Oncology 2— Scientific Review Officer, Center for
BILLING CODE 4164–01–P
Translational Clinical Integrated Review Scientific Review, National Institutes of
Group, Cancer Immunopathology and Health, 6701 Rockledge Drive, Room 6186,
Immunotherapy Study Section. MSC 7804, Bethesda, MD 20892, (301) 594–
Date: February 25–26, 2016. 2414; huzhuang@csr.nih.gov.
DEPARTMENT OF HEALTH AND Time: 8:00 a.m. to 5:00 p.m.
HUMAN SERVICES Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
applications. Program Nos. 93.306, Comparative Medicine,
National Institutes of Health Place: The Dupont Hotel, 1500 New 93.333, Clinical Research, 93.306, 93.333,
Hampshire Avenue NW., Washington, DC 93.337, 93.393–93.396, 93.837–93.844,
Center for Scientific Review; Notice of 20036. 93.846– 93.878, 93.892, 93.893, National
Closed Meetings Institutes of Health, HHS)
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Contact Person: Denise R Shaw, Ph.D.,
Scientific Review Officer, Center for Dated: January 27, 2016.
Pursuant to section 10(d) of the Scientific Review, National Institutes of
Federal Advisory Committee Act, as Michelle Trout,
Health, 6701 Rockledge Drive, Room 6158,
amended (5 U.S.C. App.), notice is MSC 7804, Bethesda, MD 20892, 301–435– Program Analyst, Office of Federal Advisory
hereby given of the following meetings. 0198; shawdeni@csr.nih.gov. Committee Policy.
The meetings will be closed to the Name of Committee: Oncology 1—Basic [FR Doc. 2016–01818 Filed 2–1–16; 8:45 am]
public in accordance with the Translational Integrated Review Group, BILLING CODE 4140–01–P
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Document Created: 2016-02-02 00:32:19
Document Modified: 2016-02-02 00:32:19
| 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 March 3, 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 5470 |
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