81 FR 78602 - Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78602-78603 | |
| FR Document | 2016-26913 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Notices] [Pages 78602-78603] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26913] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3362] Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions. DATES: Although you can comment on the PhUSE SDSP template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by January 9, 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''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food [[Page 78603]] 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-3362 for ``Intent to Review a Study Data Standardization Plan Template.'' 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: Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301- 796-8856, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is a participating member of PhUSE, an independent, non-profit consortium of academic, regulatory, non-profit, and private sector entities. PhUSE provides a global platform for the discussion of topics encompassing the work of biostatisticians, data managers, statistical programmers, and e-clinical information technology professionals, with the mission of providing an open, transparent, and collaborative forum to address computational science issues. As part of this collaboration, PhUSE working groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. You can learn more about PhUSE working groups at http://www.phuse.eu/cs-working-groups.aspx. (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.) In December 2014, FDA published the Study Data Technical Conformance Guide (the ``Guide,'' available at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm), which contains technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format. In section 2.1 of the Guide, FDA recommends that sponsors should include a plan (e.g., in the IND) describing the submission of standardized study data to FDA. FDA's Study Data Standards Resources Web page provides recommendations for preparing an SDSP (http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM447119.pdf). FDA now intends to review the PhUSE SDSP template, a deliverable of the working group effort described previously in this document, with the potential result that FDA could recommend the use of the template in its current form, or in a modified form, for use in the regulatory submission of study data in conformance with the Guide. FDA invites public comment on all matters regarding the use of the PhUSE SDSP template. II. Electronic Access The PhUSE SDSP template is available at: http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf. Dated: November 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26913 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![78602 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices
will be used to understand satisfaction Æ One week in the fall (during the 384 responses will be required (n =
among individuals who receive SHIP annual Medicare Open Enrollment 3,000,000 counseling sessions in 2015).
Medicare assistance/counseling, as well, Period) SHIP anticipates collecting 75
as how the program can be improved to • Focus only on non-redundant completed surveys per state/territory,
provide better service to its target individuals (i.e., a random sample for a total collection of 4,050 completed
population. Eighteen (18) unique states/ without replacement of individuals who surveys over the 3-year period. This
territories will be surveyed in FY 2017, receive SHIP counseling). larger collection will enable ACL to
• Randomly select 18 states and
with each state/territory expected to make state-to-state comparisons, which
territories to be surveyed each year,
generate 75 unique responses, for a total is an important feature of this survey.
with the states/territories stratified by
of 1,350 individual responses in Year 1. data collection method* and the size of Specifically, state-to-state comparisons
This process will then be replicated in the Medicare-eligible population. will allow ACL to identify which states/
Year 2 (FY 2018) and Year 3 (FY 2019), * Data collection method refers to how territories are providing the best
with a different unique group of 18 each state/territory collects and enters services to their beneficiaries, and what
states and territories being surveyed its records of counseling sessions. The best practices can be shared across
each year. By the end of FY19, SHIP majority of states/territories (29 of 54) states/territories. The larger collection
will obtain 4,050 completed surveys to directly enter counseling records into will also provide each state/territory
measure satisfaction at the state and SHIP’s National Performance Reporting with sufficient information to take local
national levels (18 states/territories × 75 (NPR) system, but the remaining states/ action to improve service within
responses per state × 3 years). SHIP will territories upload data in batches at the budgetary constraints.
use the following factors to draw a end of each month. To ensure that the The proposed survey instrument may
representative sample of beneficiaries batch upload states/territories will be be viewed on the Web site: http://
who received assistance/counseling: able to pull weekly samples twice per www.acl.gov/Programs/CIP/OHIC/
year, we will limit these states/
• Review counseling sessions at two territories to Years 2 and 3 of the survey
index.aspx.
points each year: administration period, thereby allowing OMB approval is requested for 3
Æ One week in the spring (outside of for technical assistance to these states/ years. There are no costs to respondents
the annual Medicare Open Enrollment territories if necessary. other than their time. The average
Period) To generate a sample with a 95% annual burden associated with these
confidence level at the national level activities is summarized below:
Average Total
Responses
Number of burden hours average
Respondent type per
respondents per response annual burden
respondent (hours) (hours)
Stratified Random Sample ............................................................................... 1,350 1 8/60 180
Dated: October 27, 2016. with the Pharmaceutical Users Software including attachments, to http://
Edwin L. Walker, Exchange (PhUSE), an independent, www.regulations.gov will be posted to
Acting Administrator and Assistant Secretary non-profit consortium addressing the docket unchanged. Because your
for Aging. computational science issues, a PhUSE comment will be made public, you are
[FR Doc. 2016–26924 Filed 11–7–16; 8:45 am] working group developed the PhUSE solely responsible for ensuring that your
BILLING CODE 4154–01–P SDSP template. The purpose of this comment does not include any
review is to evaluate the template and confidential information that you or a
determine whether FDA will third party may not wish to be posted,
DEPARTMENT OF HEALTH AND recommend its use either as is, or in a such as medical information, your or
HUMAN SERVICES modified form, for regulatory anyone else’s Social Security number, or
submissions of study data. FDA is confidential business information, such
Food and Drug Administration seeking public comment on the use of as a manufacturing process. Please note
[Docket No. FDA–2016–N–3362] the PhUSE SDSP template for regulatory that if you include your name, contact
submissions. information, or other information that
Intent To Review a Study Data DATES: Although you can comment on identifies you in the body of your
Standardization Plan Template; Notice the PhUSE SDSP template at any time, comments, that information will be
of Availability; Establishment of a to ensure that the Agency considers posted on http://www.regulations.gov.
Public Docket; Request for Comments • If you want to submit a comment
your comments in this review, please
with confidential information that you
AGENCY: Food and Drug Administration, submit either electronic or written
do not wish to be made available to the
HHS. comments by January 9, 2017.
public, submit the comment as a
ACTION:Notice of availability; request ADDRESSES: You may submit comments written/paper submission and in the
for comments. as follows: manner detailed (see ‘‘Written/Paper
mstockstill on DSK3G9T082PROD with NOTICES
Electronic Submissions Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
Administration (FDA), Center for Drug Submit electronic comments in the Written/Paper Submissions
Evaluation and Research, is establishing following way: Submit written/paper submissions as
a public docket to collect comments • Federal eRulemaking Portal: http:// follows:
related to a proposed Study Data www.regulations.gov. Follow the • Mail/Hand delivery/Courier (for
Standardization Plan (SDSP) template. instructions for submitting comments. written/paper submissions): Division of
As part of FDA’s ongoing collaboration Comments submitted electronically, Dockets Management (HFA–305), Food
VerDate Sep<11>2014 16:27 Nov 07, 2016 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1](https://thefederalregister.org/doc/81_FR_78818/page/1.svg)
![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices 78603
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. all matters regarding the use of the
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. PhUSE SDSP template.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: II. Electronic Access
submitted to the Division of Dockets Crystal Allard, Center for Drug
Management, FDA will post your The PhUSE SDSP template is
Evaluation and Research, Food and
comment, as well as any attachments, available at: http://www.phusewiki.org/
Drug Administration, 10903 New
except for information submitted, wiki/images/e/ea/SDSP_Template.pdf.
Hampshire Ave., Bldg. 21, Rm. 1518,
marked and identified, as confidential, Silver Spring, MD 20993–0002, 301– Dated: November 2, 2016.
if submitted as detailed in 796–8856, crystal.allard@fda.hhs.gov. Leslie Kux,
‘‘Instructions.’’ Associate Commissioner for Policy.
Instructions: All submissions received SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–26913 Filed 11–7–16; 8:45 am]
must include the Docket No. FDA– I. Background BILLING CODE 4164–01–P
2016–N–3362 for ‘‘Intent to Review a
Study Data Standardization Plan FDA is a participating member of
Template.’’ Received comments will be PhUSE, an independent, non-profit
consortium of academic, regulatory, DEPARTMENT OF HEALTH AND
placed in the docket and, except for HUMAN SERVICES
those submitted as ‘‘Confidential non-profit, and private sector entities.
Submissions,’’ publicly viewable at PhUSE provides a global platform for Food and Drug Administration
http://www.regulations.gov or at the the discussion of topics encompassing
the work of biostatisticians, data [Docket No. FDA–2013–D–0743]
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday managers, statistical programmers, and
e-clinical information technology Medical Device Reporting for
through Friday. Manufacturers; Guidance for Industry
• Confidential Submissions—To professionals, with the mission of
providing an open, transparent, and and Food and Drug Administration
submit a comment with confidential Staff; Availability
information that you do not wish to be collaborative forum to address
made publicly available, submit your computational science issues. As part of AGENCY: Food and Drug Administration,
comments only as a written/paper this collaboration, PhUSE working HHS.
submission. You should submit two groups develop and periodically publish ACTION: Notice of availability.
copies total. One copy will include the proposals for enhancing the review and
information you claim to be confidential analysis of human and animal study SUMMARY: The Food and Drug
with a heading or cover note that states data submitted to regulatory agencies. Administration (FDA) is announcing the
‘‘THIS DOCUMENT CONTAINS You can learn more about PhUSE availability of the guidance entitled
CONFIDENTIAL INFORMATION.’’ The working groups at http://www.phuse.eu/ ‘‘Medical Device Reporting for
Agency will review this copy, including cs-working-groups.aspx. (FDA has Manufacturers; Guidance for Industry
the claimed confidential information, in verified the Web site addresses as of the and Food and Drug Administration
its consideration of comments. The date this document publishes in the Staff.’’ This guidance document is
second copy, which will have the Federal Register, but Web sites are intended to assist medical device
claimed confidential information subject to change over time.) manufacturers meet applicable reporting
redacted/blacked out, will be available In December 2014, FDA published the and recordkeeping requirements for
for public viewing and posted on http:// Study Data Technical Conformance certain device-related adverse events
www.regulations.gov. Submit both Guide (the ‘‘Guide,’’ available at http:// and malfunctions.
copies to the Division of Dockets www.fda.gov/ForIndustry/ DATES: Submit either electronic or
Management. If you do not wish your DataStandards/StudyDataStandards/ written comments on this guidance at
name and contact information to be default.htm), which contains technical any time. General comments on Agency
made publicly available, you can recommendations to sponsors for the guidance documents are welcome at any
provide this information on the cover submission of animal and human study time.
sheet and not in the body of your data and related information in a ADDRESSES: You may submit comments
comments and you must identify this standardized electronic format. In as follows:
information as ‘‘confidential.’’ Any section 2.1 of the Guide, FDA
information marked as ‘‘confidential’’ recommends that sponsors should Electronic Submissions
will not be disclosed except in include a plan (e.g., in the IND) Submit electronic comments in the
accordance with 21 CFR 10.20 and other describing the submission of following way:
applicable disclosure law. For more standardized study data to FDA. FDA’s • Federal eRulemaking Portal: http://
information about FDA’s posting of Study Data Standards Resources Web www.regulations.gov. Follow the
comments to public dockets, see 80 FR page provides recommendations for instructions for submitting comments.
56469, September 18, 2015, or access preparing an SDSP (http://www.fda.gov/ Comments submitted electronically,
the information at: http://www.fda.gov/ downloads/ForIndustry/DataStandards/ including attachments, to http://
regulatoryinformation/dockets/ StudyDataStandards/UCM447119.pdf). www.regulations.gov/ will be posted to
default.htm. FDA now intends to review the the docket unchanged. Because your
Docket: For access to the docket to PhUSE SDSP template, a deliverable of comment will be made public, you are
read background documents or the the working group effort described solely responsible for ensuring that your
mstockstill on DSK3G9T082PROD with NOTICES
electronic and written/paper comments previously in this document, with the comment does not include any
received, go to http:// potential result that FDA could confidential information that you or a
www.regulations.gov and insert the recommend the use of the template in third party may not wish to be posted,
docket number, found in brackets in the its current form, or in a modified form, such as medical information, your or
heading of this document, into the for use in the regulatory submission of anyone else’s Social Security number, or
‘‘Search’’ box and follow the prompts study data in conformance with the confidential business information, such
and/or go to the Division of Dockets Guide. FDA invites public comment on as a manufacturing process. Please note
VerDate Sep<11>2014 16:27 Nov 07, 2016 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1](https://thefederalregister.org/doc/81_FR_78818/page/2.svg)
Document Created: 2018-02-14 08:24:02
Document Modified: 2018-02-14 08:24:02
| 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 of availability; request for comments. | |
| Dates | Although you can comment on the PhUSE SDSP template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by January 9, 2017. | |
| Contact | Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301- 796-8856, [email protected] | |
| FR Citation | 81 FR 78602 |
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