81 FR 78161 - Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 215 (November 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 215 (November 7, 2016)
| Page Range | 78161-78163 | |
| FR Document | 2016-26794 |
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)] [Notices] [Pages 78161-78163] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26794] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3586] Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection resulting from focus groups about drug products as used by FDA. DATES: Submit either electronic or written comments on the collection of information by January 6, 2017. ADDRESSES: You may submit comments as follows: 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''). [[Page 78162]] 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-3586 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration.'' 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. 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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, including each proposed extension of an existing 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. Focus Groups About Drug Products as Used by the Food and Drug Administration, OMB Control Number 0910-0677--Extension Focus groups provide an important role in gathering information because they allow for a more indepth understanding of individuals' attitudes, beliefs, motivations, and feelings than do quantitative studies. Focus groups serve the narrowly defined need for direct and informal opinion on a specific topic and as a qualitative research tool have three major purposes: To obtain information that is useful for developing variables and measures for quantitative studies; to better understand people's attitudes and emotions in response to topics and concepts; and to further explore findings obtained from quantitative studies. FDA will use focus group findings to test and refine its ideas and to help develop messages and other communications, but will generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. FDA's Center for Drug Evaluation and Research, Office of the Commissioner, and any other Centers or Offices conducting focus groups about regulated drug products may need to conduct focus groups on a variety of subjects related to consumer, patient, or health care professional perceptions and use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, Medication Guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sales of medical products, and consumer and professional education. Annually, FDA projects about 20 focus group studies using 160 focus groups with an average of 9 persons per group, and lasting an average of 1.75 hours each. FDA is requesting this burden for unplanned focus groups so as not to restrict the Agency's ability to gather information on public sentiment for its proposals in its regulatory and communications programs. FDA estimates the burden of this information collection as follows: [[Page 78163]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Information collection activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Focus Groups About Drug Products................................... 1,440 1 1,440 1.75 2,520 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26794 Filed 11-4-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices 78161
Department of Health and Human foster care and are most likely to have will be used to assess grantees’
Services (HHS) intends to collect data a challenging transition into adulthood, organizational capacity to implement
for an evaluation of the initiative, including homelessness and unstable and evaluate the model interventions
Implementation Grants to Develop a housing experiences. CB awarded six and to monitor each grantee’s progress
Model Intervention for Youth/Young implementation grants (Phase II) in toward achieving the goals of the
Adults with Child Welfare Involvement September 2015. During the implementation period.
at Risk of Homelessness: Phase II. This implementation phase, organizations
builds on the previously approved will conduct a range of activities to fine- Data for the process evaluation will be
‘‘Planning Grants to Develop a Model tune their comprehensive service collected through: Interviews during site
Intervention for Youth/Young Adults model, determine whether their model visits.
with Child Welfare Involvement at Risk is being implemented as intended, and Respondents: Grantee agency
of Homelessness’’ (Phase I). Phase II is develop plans to evaluate the model directors and staff; partner agency
an initiative, funded by the Children’s under a potential future funding directors and staff. Partner agencies may
Bureau (CB) within ACF, that will opportunity (Phase III). During Phase II, vary by site, but are expected to include
support implementation grants for ACF will engage a contractor to: child welfare, mental health, and youth
interventions designed to intervene with Conduct a cross-site process evaluation. housing/homelessness agencies.
youth who have experienced time in Data collected for the process evaluation
ANNUAL BURDEN ESTIMATES
Total/annual Number of Average Total/annual
Instrument number of responses per burden hours burden hours
respondents respondent per response
Call to coordinate site visit .............................................................................. 6 1 1 6
Grantee Site Visit-Semi-Structured Interview Topic Guide ............................. 60 1 1.5 90
Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 96
In compliance with the requirements comments and suggestions submitted from focus groups about drug products
of Section 3506(c)(2)(A) of the within 60 days of this publication. as used by FDA.
Paperwork Reduction Act of 1995, the Mary Jones, DATES: Submit either electronic or
Administration for Children and written comments on the collection of
ACF/OPRE Certifying Officer.
Families is soliciting public comment information by January 6, 2017.
[FR Doc. 2016–26806 Filed 11–4–16; 8:45 am]
on the specific aspects of the ADDRESSES: You may submit comments
BILLING CODE 4184–01–P
information collection described above. as follows:
Copies of the proposed collection of
information can be obtained and Electronic Submissions
DEPARTMENT OF HEALTH AND
comments may be forwarded by writing HUMAN SERVICES Submit electronic comments in the
to the Administration for Children and following way:
Families, Office of Planning, Research, Food and Drug Administration • Federal eRulemaking Portal: http://
and Evaluation, 330 C Street SW., www.regulations.gov. Follow the
[Docket No. FDA–2016–N–3586] instructions for submitting comments.
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email Comments submitted electronically,
Agency Information Collection
address: OPREinfocollection@ including attachments, to http://
Activities; Proposed Collection;
acf.hhs.gov. All requests should be www.regulations.gov will be posted to
Comment Request; Focus Groups
identified by the title of the information the docket unchanged. Because your
About Drug Products as Used by the
collection. comment will be made public, you are
Food and Drug Administration
solely responsible for ensuring that your
The Department specifically requests AGENCY: Food and Drug Administration, comment does not include any
comments on (a) whether the proposed HHS. confidential information that you or a
collection of information is necessary third party may not wish to be posted,
ACTION: Notice.
for the proper performance of the such as medical information, your or
functions of the agency, including SUMMARY: The Food and Drug anyone else’s Social Security number, or
whether the information shall have Administration (FDA) is announcing an confidential business information, such
practical utility; (b) the accuracy of the opportunity for public comment on the as a manufacturing process. Please note
agency’s estimate of the burden of the proposed collection of certain that if you include your name, contact
proposed collection of information; (c) information by the Agency. Under the information, or other information that
the quality, utility, and clarity of the Paperwork Reduction Act of 1995 (the identifies you in the body of your
information to be collected; and (d) PRA), Federal Agencies are required to comments, that information will be
publish notice in the Federal Register posted on http://www.regulations.gov.
sradovich on DSK3GMQ082PROD with NOTICES
ways to minimize the burden of the
collection of information on concerning each proposed collection of • If you want to submit a comment
respondents, including through the use information, including each proposed with confidential information that you
of automated collection techniques or extension of an existing collection of do not wish to be made available to the
other forms of information technology. information, and to allow 60 days for public, submit the comment as a
Consideration will be given to public comment in response to the written/paper submission and in the
notice. This notice solicits comments on manner detailed (see ‘‘Written/Paper
the information collection resulting Submissions’’ and ‘‘Instructions’’).
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![Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices 78163
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Information collection activity responses per burden per Total hours
respondents responses
respondent response
Focus Groups About Drug Products ................................... 1,440 1 1,440 1.75 2,520
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 1, 2016. www.regulations.gov will be posted to information you claim to be confidential
Leslie Kux, the docket unchanged. Because your with a heading or cover note that states
Associate Commissioner for Policy. comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2016–26794 Filed 11–4–16; 8:45 am] solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
comment does not include any Agency will review this copy, including
confidential information that you or a the claimed confidential information, in
third party may not wish to be posted, its consideration of comments. The
DEPARTMENT OF HEALTH AND such as medical information, your or second copy, which will have the
HUMAN SERVICES anyone else’s Social Security number, or claimed confidential information
confidential business information, such redacted/blacked out, will be available
Food and Drug Administration as a manufacturing process. Please note for public viewing and posted on http://
that if you include your name, contact www.regulations.gov. Submit both
[Docket No. FDA–2016–N–3585]
information, or other information that copies to the Division of Dockets
Agency Information Collection identifies you in the body of your Management. If you do not wish your
Activities; Proposed Collection; comments, that information will be name and contact information to be
Comment Request; Character-Space- posted on http://www.regulations.gov. made publicly available, you can
Limited Online Prescription Drug • If you want to submit a comment provide this information on the cover
Communications with confidential information that you sheet and not in the body of your
do not wish to be made available to the comments and you must identify this
AGENCY: Food and Drug Administration, public, submit the comment as a information as ‘‘confidential.’’ Any
HHS. written/paper submission and in the information marked as ‘‘confidential’’
ACTION: Notice. manner detailed (see ‘‘Written/Paper will not be disclosed except in
Submissions’’ and ‘‘Instructions’’). accordance with 21 CFR 10.20 and other
SUMMARY: The Food and Drug applicable disclosure law. For more
Administration (FDA) is announcing an Written/Paper Submissions information about FDA’s posting of
opportunity for public comment on the Submit written/paper submissions as comments to public dockets, see 80 FR
proposed collection of certain follows: 56469, September 18, 2015, or access
information by the Agency. Under the • Mail/Hand delivery/Courier (for the information at: http://www.fda.gov/
Paperwork Reduction Act of 1995 (the written/paper submissions): Division of regulatoryinformation/dockets/
PRA), Federal Agencies are required to Dockets Management (HFA–305), Food default.htm.
publish notice in the Federal Register and Drug Administration, 5630 Fishers Docket: For access to the docket to
concerning each proposed collection of Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
information and to allow 60 days for • For written/paper comments electronic and written/paper comments
public comment in response to the submitted to the Division of Dockets received, go to http://
notice. This notice solicits comments on Management, FDA will post your www.regulations.gov and insert the
research entitled, ‘‘Character-Space- comment, as well as any attachments, docket number, found in brackets in the
Limited Online Prescription Drug except for information submitted, heading of this document, into the
Communications.’’ The objective of this marked and identified, as confidential, ‘‘Search’’ box and follow the prompts
research is to test whether a link to if submitted as detailed in and/or go to the Division of Dockets
prescription drug risk information can ‘‘Instructions.’’ Management, 5630 Fishers Lane, Rm.
effectively convey the risks associated Instructions: All submissions received 1061, Rockville, MD 20852.
with a drug when benefit claims about must include the Docket No. FDA– FOR FURTHER INFORMATION CONTACT: FDA
that drug are made within character- 2016–N–3585 for ‘‘Character-Space- PRA Staff, Office of Operations, Food
space-limited communications used in Limited Online Prescription Drug and Drug Administration, Three White
prescription drug promotion. Communications.’’ Received comments Flint North, 10A63, 11601 Landsdown
DATES: Submit either electronic or will be placed in the docket and, except St., North Bethesda, MD 20852,
written comments on the collection of for those submitted as ‘‘Confidential PRAStaff@fda.hhs.gov.
information by January 6, 2017. Submissions,’’ publicly viewable at SUPPLEMENTARY INFORMATION:
ADDRESSES: You may submit comments http://www.regulations.gov or at the
Division of Dockets Management I. Background
as follows:
between 9 a.m. and 4 p.m., Monday Under the PRA (44 U.S.C. 3501–
Electronic Submissions 3520), Federal Agencies must obtain
sradovich on DSK3GMQ082PROD with NOTICES
through Friday.
Submit electronic comments in the • Confidential Submissions—To approval from the Office of Management
following way: submit a comment with confidential and Budget (OMB) for each collection of
• Federal eRulemaking Portal: http:// information that you do not wish to be information they conduct or sponsor.
www.regulations.gov. Follow the made publicly available, submit your ‘‘Collection of information’’ is defined
instructions for submitting comments. comments only as a written/paper in 44 U.S.C. 3502(3) and 5 CFR
Comments submitted electronically, submission. You should submit two 1320.3(c) and includes Agency requests
including attachments, to http:// copies total. One copy will include the or requirements that members of the
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Document Created: 2018-02-14 08:21:18
Document Modified: 2018-02-14 08:21:18
| 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 January 6, 2017. | |
| 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 78161 |
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