Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments, 33421-33423 [2013-13083]

Download as PDF Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices 5. Section 508 Compliance— Contestants must acknowledge that they understand that, as a pre-requisite to any subsequent acquisition by FAR contract or other method, they may be required to make their proposed solution compliant with Section 508 accessibility and usability requirements at their own expense. Any electronic information technology that is ultimately obtained by HHS for its use, development, or maintenance must meet Section 508 accessibility and usability standards. Past experience has demonstrated that it can be costly for solution-providers to ‘‘retrofit’’ solutions if remediation is later needed. The HHS Section 508 Evaluation Product Assessment Template, available at https://www.hhs.gov/web/508/ contracting/technology/vendors.html, provides a useful roadmap for developers to review. It is a simple, web-based checklist utilized by HHS officials to allow vendors to document how their products do or do not meet the various Section 508 requirements. 6. Functionality/Accuracy—A Submission may be disqualified if the application fails to function as expressed in the description provided by the user, or if the application provides inaccurate or incomplete information. 7. Security—Submissions must be free of malware. Contestant agrees that ONC may conduct testing on the application to determine whether malware or other security threats may be present. ONC may disqualify the application if, in ONC’s judgment, the application may damage government or others’ equipment or operating environment. tkelley on DSK3SPTVN1PROD with NOTICES Additional Information Ownership of intellectual property is determined by the following: • Patient Application category entrants retain title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. • Developer Tools category entrants are required to post their tools on GitHub to be made available via open source. • By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for VerDate Mar<15>2010 18:33 Jun 03, 2013 Jkt 229001 advertising and promotional purposes relating to the challenge. Authority: 15 U.S.C. 3719 Dated: May 28, 2013. Farzad Mostashari, National Coordinator for Health Information Technology. [FR Doc. 2013–13128 Filed 6–3–13; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer’s Research, Care, and Services Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services. ACTION: Request for Nominations. AGENCY: SUMMARY: HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer’s Research, Care, and Services. Specifically, the position is for someone with a diagnosis of Alzheimer’s disease or a related dementia. Nominations should include the nominee’s contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume. Nominations submitted within the past 6 months for other positions on the Advisory Council on Alzheimer’s Research, Care, and Services will be considered for this position. DATES: Submit nominations by email or FedEx or UPS before COB on June 14, 2013. ADDRESSES: Nominations should be sent to Helen Lamont at helen.lamont@hhs.gov; Helen Lamont, Ph.D., Office of the Assistant Secretary for Planning and Evaluation, Room 424E Humphrey Building, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Helen Lamont (202) 690–7996, helen.lamont@hhs.gov. SUPPLEMENTARY INFORMATION: The Advisory Council on Alzheimer’s Research, Care, and Services meets quarterly to discuss programs that impact people with Alzheimer’s disease and related dementias and their caregivers. The Advisory Council makes recommendations about ways to reduce the financial impact of Alzheimer’s disease and related dementias and to improve the health outcomes of people with these conditions. The Advisory PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 33421 Council provides feedback on the National Plan to Address Alzheimer’s Disease. On an annual basis, the Advisory Council shall evaluate the implementation of the recommendations through an updated national plan. The Advisory Council consists of designees from Federal agencies including the Centers for Disease Control and Prevention, Administration on Aging, Centers for Medicare and Medicaid Services, Indian Health Service, Office of the Director of the National Institutes of Health, National Science Foundation, Department of Veterans Affairs, Food and Drug Administration, Agency for Healthcare Research and Quality, and the Surgeon General. The Advisory Council also consists of 13 non-federal members selected by the Secretary who are Alzheimer’s patient advocates (2), Alzheimer’s caregivers (2), health care providers (2), representatives of State health departments (2), researchers with Alzheimer’s-related expertise in basic, translational, clinical, or drug development science (2), voluntary health association representatives (2), and a person with a diagnosis of Alzheimer’s disease or a related dementia. Members serve as Special Government Employees. This announcement is seeking nominations for a person with a diagnosis of Alzheimer’s disease or a related dementia who is not a Federal employee. This person will serve a twoyear term. Dated: May 28, 2013. Donald B. Moulds, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2013–13127 Filed 6–3–13; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0271] Availability of Masked and Deidentified Non-Summary Safety and Efficacy Data; Request for Comments ACTION: Notice; request for comments. AGENCY: Food and Drug Administration, HHS. SUMMARY: The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of deidentified and masked data derived from medical product applications. Improving the efficiency and E:\FR\FM\04JNN1.SGM 04JNN1 33422 Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES effectiveness of medical product development is a national priority. The ability to make available de-identified and masked clinical and preclinical data derived from marketing applications could make an important contribution to that goal by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products. The contribution of patients who participate in clinical trials should be maximized for the benefit of society. The Agency invites comments on the issues to be considered with regard to such availability and on any limitations that should be placed on the availability of these data. DATES: Submit either electronic or written comments by August 5, 2013. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets at the heading of this document. FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., HILL–3110, Silver Spring, MD 20993, 301–796–3603, FAX: 301–431–6351, Nancy.sager@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Aaliyah EavesLeanos, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5435, 301–796–2948, FAX: 301–847–8510. Aaliyah.EavesLeanos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Commissioner of Food and Drugs Margaret Hamburg has emphasized FDA’s role as a public health Agency (Ref. 1). In accordance with its responsibility to promote the public health, FDA has, in collaboration with the National Institutes of Health, launched the Regulatory Science Initiative, a call to action to enhance the science and knowledge critical to improving the development, manufacture, evaluation, and safe use of critically needed new therapies. In addition, the Food and Drug Administration Safety and Innovation VerDate Mar<15>2010 18:33 Jun 03, 2013 Jkt 229001 Act (FDASIA), enacted on July 9, 2012, contains important new authorities that will enhance the Agency’s ability to promote innovation across industry, research and clinical care settings, including new provisions that require the development of a plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision making. (See, e.g., section 1124 of FDASIA (Pub. L. 112–144).) The development of new knowledge and insights from clinical and preclinical study data is an important regulatory science opportunity. These data have a tremendous potential to help address critical challenges and provide new opportunities for innovation in medical product development, including for human drugs, medical devices, and biological products. Safety and effectiveness data from multiple studies have been used in the past to address key hurdles in drug development. Analysis of data from multiple clinical and preclinical studies has been used to identify potentially valid endpoints for clinical trials, understand the predictive value of preclinical models, clarify how medical products work in different diseases, and inform development of novel clinical designs and endpoints to the benefit of patients. For example, the primary endpoint for chronic hepatitis C trials has been based on detection of hepatitis C virus at week 24 of follow up. Evidence suggested that assessing the response at earlier follow up time points may provide an equivalent measurement of drug response. FDA scientists conducted an analysis of the combined data from 15 clinical trials and 3 pediatric trials from 5 drug development programs to determine whether assessments conducted at earlier time points could provide results that were predictive of the outcomes at 24 weeks of follow up (Ref. 2). The sustained virologic response measurements at 12 and 24 weeks of follow up were concordant across a large population database involving multiple trials, viral genotypes, treatment regimens, and durations. The sustained virologic response at 12 weeks of follow up was determined to be suitable as a primary endpoint in clinical trials and allows for hepatitis C virus treatment options to be available earlier for patients suffering from this disease. The sustained virologic response at 4 weeks of follow up may have utility in guiding dose and treatment strategies when designing registration trials. The use of earlier time points for key regulatory decisions and dose selection may facilitate drug PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 development for additional therapeutics under investigation. In addition to identification of additional endpoints for clinical studies, pooled data (both preclinical and clinical) have also been applied to the analysis of safety issues. An analysis of 199 clinical trials of 11 antiepileptic drugs by FDA helped quantify the increased risk of suicidal behavior or ideation for patients and prescribers. (Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality (May 23, 2008): https://www.fda.gov/ downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationfor PatientsandProviders/UCM192556.pdf.) An independent analysis of data on 5 potential biomarkers of kidney injury by the Predictive Safety Testing Consortium led to their qualification for inclusion in pre-clinical safety data submissions (Ref. 3). These markers are now being evaluated for their utility as more sensitive markers of early kidney damage in human clinical trials. Thus, advances in regulatory science can arise from analysis of diverse data submitted as part of marketing applications, including, for example data related to clinical outcomes, safety, biomarker status, drug disposition, drug action, or patient reported outcomes. (See, e.g., 21 CFR 314.50 (specifying the content of new drug applications).) FDA has considerable expertise in analyzing individual patient level and aggregated clinical trial data, but recognizes the potential to further advance regulatory science by allowing other experts the opportunity to contribute to these efforts. To fully realize the potential of these data, experts outside of FDA would need to become actively engaged in the research. FDA is considering approaches to providing access by nonFDA experts and other interested parties to data that have research value in a way that would both safeguard the privacy interests of patients enrolled in clinical trials, and appropriately protect the commercial investments of sponsors. Consistent with and in furtherance of the objectives and mission of Commissioner Hamburg’s Transparency Initiative, FDA intends to consider the extent and nature of public availability of de-identified and masked subject level data necessary to achieve specific aims. For more information on the Transparency Initiative, see https://www. fda.gov/AboutFDA/Transparency/ TransparencyInitiative/default.htm. FDA uses the term ‘‘masked data’’ in this notice to refer to data with information removed that could link it to a specific product or application. The Agency will consider different strategies E:\FR\FM\04JNN1.SGM 04JNN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices to minimize the ability to identify specific products and the impact of any such strategies. Such strategies might include making available certain data from a random sample or appropriately chosen subset of subjects, restricting the data fields made available or pooling data where possible from studies of multiple members of a product class, without identifying the specific product. For the purposes of this notice, deidentified data refers to data that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual. Cf. 45 CFR 164.514(a) (although FDA references the standard used in the Privacy Rule here, the Agency notes that it is not a covered entity for the purposes of that Rule). The Agency has an unwavering commitment to protecting the privacy of research subjects’ identities. As such, consistent with FDA’s regulations at 21 CFR 20.63(a), any data that might be made available under this proposal would be stripped of any information which could identify patients or research subjects, either directly or through combination with other publicly available information. See id. (‘‘The names and other information which would identify patients or research subjects . . . shall be deleted before the record is made available for public disclosure.’’) This same regulation also directs outside parties to remove such personal identifiers from records prior to submission to FDA. (See § 20.63(b).) De-identified and masked data could be used to advance public health. For example, a model of disease progression in control arms of future studies could be based on pooled control group data from past studies of the same disease or indication and would not require identification of a product or even product class nor would there be personal identifiers associated with the data. Similarly, characterization of risk factors might only involve control group data. On the other hand, validating a biomarker as a surrogate for a clinical outcome or as a predictive classifier of potential treatment response might require identification of products by class or analysis across a class to show consistency. We note that this proposal contemplates the availability of certain data after appropriate steps have been taken to de-identify it and remove the data’s link to a specific product, study, or application. This proposal does not pertain to unmasked safety and effectiveness data, (i.e., data that can be linked to a specific, identified application) including full study VerDate Mar<15>2010 18:33 Jun 03, 2013 Jkt 229001 reports; the circumstances under which this information is disclosed is already specifically set forth in the Federal Food Drug and Cosmetic Act and FDA’s regulations. Further, FDA will not make available business-related confidential commercial information contained in product applications, including but not limited to information concerning licensing agreements and information identifying suppliers, unless such information has already been publicly disclosed by the sponsor. Nor will the Agency make available trade secret information under this proposal. Such information will continue to be treated in a manner consistent with sections 301(j), 505(l), 520(c), 535(d), and 537(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j), 351(l), 360j(c), 360ll(d), and 360nn); the Trade Secrets Act (18 U.S.C. 1905); and FDA’s regulations (21 CFR 20.61, 314.430, 601.51, and 814.9). II. Request for Comments FDA is interested in receiving comments from the public on the following topics: (1) What factors should be considered in masking study data (e.g., data fields from regulatory submissions to remove or modify, number of different products to pool within a product class), (2) what limitations, if any, should there be on the Agency’s ability to make available the masked data as described previously, (3) are there any additional factors FDA should consider in deidentifying data in addition to FDA’s requirement to remove any names and other information (e.g., birth date, death date, local geographic information, contact information) which would identify patients or research subjects before disclosing information, (4) would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful, and (5) which situations do you believe disclosing masked data would be most useful to advance public health? Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify the question your comment addresses by the number assigned to that question. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 33423 posted to the docket at https:// www.regulations.gov. III. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at https:// www.regulations.gov. (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Hamburg, M. A. and J. M. Sharfstein, ‘‘The FDA as a Public Health Agency,’’ New England Journal of Medicine, 2009 June 11; 360(24):2493–5. 2. Chen J., J. Florian, W. Carter, et al. ‘‘Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies.’’ Gastroenterology, 2013 March 4 https:// www.sciencedirect.com/science/article/pii/ S0016508513002886 3. Dieterle, F., et al., ‘‘Renal Biomarker Qualification Submission: A Dialog Between the FDA–EMEA and Predictive Safety Testing Consortium,’’ Nature Biotechnology, 2010 May; 28(5):455–62. Dated: May 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–13083 Filed 6–3–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 23, 2013, from 8 a.m. to 5:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Pages 33421-33423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13083]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0271]


Availability of Masked and De-identified Non-Summary Safety and 
Efficacy Data; Request for Comments

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is seeking public 
comments from interested persons on the proposed availability of de-
identified and masked data derived from medical product applications. 
Improving the efficiency and

[[Page 33422]]

effectiveness of medical product development is a national priority. 
The ability to make available de-identified and masked clinical and 
preclinical data derived from marketing applications could make an 
important contribution to that goal by providing scientific data that 
may be of value in the generation of new knowledge to facilitate 
innovation in the development and evaluation of critically needed 
medical products. The contribution of patients who participate in 
clinical trials should be maximized for the benefit of society. The 
Agency invites comments on the issues to be considered with regard to 
such availability and on any limitations that should be placed on the 
availability of these data.

DATES: Submit either electronic or written comments by August 5, 2013.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets at the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., HILL-3110, Silver Spring, MD 20993, 301-796-3603, FAX: 
301-431-6351, Nancy.sager@fda.hhs.gov; or Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210; or Aaliyah Eaves-Leanos, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5435, 301-796-2948, FAX: 301-847-8510. 
Aaliyah.Eaves-Leanos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Commissioner of Food and Drugs Margaret Hamburg has emphasized 
FDA's role as a public health Agency (Ref. 1). In accordance with its 
responsibility to promote the public health, FDA has, in collaboration 
with the National Institutes of Health, launched the Regulatory Science 
Initiative, a call to action to enhance the science and knowledge 
critical to improving the development, manufacture, evaluation, and 
safe use of critically needed new therapies. In addition, the Food and 
Drug Administration Safety and Innovation Act (FDASIA), enacted on July 
9, 2012, contains important new authorities that will enhance the 
Agency's ability to promote innovation across industry, research and 
clinical care settings, including new provisions that require the 
development of a plan for advancing regulatory science for medical 
products in order to promote the public health and advance innovation 
in regulatory decision making. (See, e.g., section 1124 of FDASIA (Pub. 
L. 112-144).)
    The development of new knowledge and insights from clinical and 
preclinical study data is an important regulatory science opportunity. 
These data have a tremendous potential to help address critical 
challenges and provide new opportunities for innovation in medical 
product development, including for human drugs, medical devices, and 
biological products. Safety and effectiveness data from multiple 
studies have been used in the past to address key hurdles in drug 
development. Analysis of data from multiple clinical and preclinical 
studies has been used to identify potentially valid endpoints for 
clinical trials, understand the predictive value of preclinical models, 
clarify how medical products work in different diseases, and inform 
development of novel clinical designs and endpoints to the benefit of 
patients.
    For example, the primary endpoint for chronic hepatitis C trials 
has been based on detection of hepatitis C virus at week 24 of follow 
up. Evidence suggested that assessing the response at earlier follow up 
time points may provide an equivalent measurement of drug response. FDA 
scientists conducted an analysis of the combined data from 15 clinical 
trials and 3 pediatric trials from 5 drug development programs to 
determine whether assessments conducted at earlier time points could 
provide results that were predictive of the outcomes at 24 weeks of 
follow up (Ref. 2). The sustained virologic response measurements at 12 
and 24 weeks of follow up were concordant across a large population 
database involving multiple trials, viral genotypes, treatment 
regimens, and durations. The sustained virologic response at 12 weeks 
of follow up was determined to be suitable as a primary endpoint in 
clinical trials and allows for hepatitis C virus treatment options to 
be available earlier for patients suffering from this disease. The 
sustained virologic response at 4 weeks of follow up may have utility 
in guiding dose and treatment strategies when designing registration 
trials. The use of earlier time points for key regulatory decisions and 
dose selection may facilitate drug development for additional 
therapeutics under investigation.
    In addition to identification of additional endpoints for clinical 
studies, pooled data (both preclinical and clinical) have also been 
applied to the analysis of safety issues. An analysis of 199 clinical 
trials of 11 antiepileptic drugs by FDA helped quantify the increased 
risk of suicidal behavior or ideation for patients and prescribers. 
(Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality 
(May 23, 2008): https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM192556.pdf.) 
An independent analysis of data on 5 potential biomarkers of kidney 
injury by the Predictive Safety Testing Consortium led to their 
qualification for inclusion in pre-clinical safety data submissions 
(Ref. 3). These markers are now being evaluated for their utility as 
more sensitive markers of early kidney damage in human clinical trials. 
Thus, advances in regulatory science can arise from analysis of diverse 
data submitted as part of marketing applications, including, for 
example data related to clinical outcomes, safety, biomarker status, 
drug disposition, drug action, or patient reported outcomes. (See, 
e.g., 21 CFR 314.50 (specifying the content of new drug applications).)
    FDA has considerable expertise in analyzing individual patient 
level and aggregated clinical trial data, but recognizes the potential 
to further advance regulatory science by allowing other experts the 
opportunity to contribute to these efforts. To fully realize the 
potential of these data, experts outside of FDA would need to become 
actively engaged in the research. FDA is considering approaches to 
providing access by non-FDA experts and other interested parties to 
data that have research value in a way that would both safeguard the 
privacy interests of patients enrolled in clinical trials, and 
appropriately protect the commercial investments of sponsors.
    Consistent with and in furtherance of the objectives and mission of 
Commissioner Hamburg's Transparency Initiative, FDA intends to consider 
the extent and nature of public availability of de-identified and 
masked subject level data necessary to achieve specific aims. For more 
information on the Transparency Initiative, see https://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm.
    FDA uses the term ``masked data'' in this notice to refer to data 
with information removed that could link it to a specific product or 
application. The Agency will consider different strategies

[[Page 33423]]

to minimize the ability to identify specific products and the impact of 
any such strategies. Such strategies might include making available 
certain data from a random sample or appropriately chosen subset of 
subjects, restricting the data fields made available or pooling data 
where possible from studies of multiple members of a product class, 
without identifying the specific product.
    For the purposes of this notice, de-identified data refers to data 
that does not identify an individual and with respect to which there is 
no reasonable basis to believe that the information can be used to 
identify an individual. Cf. 45 CFR 164.514(a) (although FDA references 
the standard used in the Privacy Rule here, the Agency notes that it is 
not a covered entity for the purposes of that Rule). The Agency has an 
unwavering commitment to protecting the privacy of research subjects' 
identities. As such, consistent with FDA's regulations at 21 CFR 
20.63(a), any data that might be made available under this proposal 
would be stripped of any information which could identify patients or 
research subjects, either directly or through combination with other 
publicly available information. See id. (``The names and other 
information which would identify patients or research subjects . . . 
shall be deleted before the record is made available for public 
disclosure.'') This same regulation also directs outside parties to 
remove such personal identifiers from records prior to submission to 
FDA. (See Sec.  20.63(b).)
    De-identified and masked data could be used to advance public 
health. For example, a model of disease progression in control arms of 
future studies could be based on pooled control group data from past 
studies of the same disease or indication and would not require 
identification of a product or even product class nor would there be 
personal identifiers associated with the data. Similarly, 
characterization of risk factors might only involve control group data. 
On the other hand, validating a biomarker as a surrogate for a clinical 
outcome or as a predictive classifier of potential treatment response 
might require identification of products by class or analysis across a 
class to show consistency.
    We note that this proposal contemplates the availability of certain 
data after appropriate steps have been taken to de-identify it and 
remove the data's link to a specific product, study, or application. 
This proposal does not pertain to unmasked safety and effectiveness 
data, (i.e., data that can be linked to a specific, identified 
application) including full study reports; the circumstances under 
which this information is disclosed is already specifically set forth 
in the Federal Food Drug and Cosmetic Act and FDA's regulations. 
Further, FDA will not make available business-related confidential 
commercial information contained in product applications, including but 
not limited to information concerning licensing agreements and 
information identifying suppliers, unless such information has already 
been publicly disclosed by the sponsor. Nor will the Agency make 
available trade secret information under this proposal. Such 
information will continue to be treated in a manner consistent with 
sections 301(j), 505(l), 520(c), 535(d), and 537(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(j), 351(l), 360j(c), 
360ll(d), and 360nn); the Trade Secrets Act (18 U.S.C. 1905); and FDA's 
regulations (21 CFR 20.61, 314.430, 601.51, and 814.9).

II. Request for Comments

    FDA is interested in receiving comments from the public on the 
following topics: (1) What factors should be considered in masking 
study data (e.g., data fields from regulatory submissions to remove or 
modify, number of different products to pool within a product class), 
(2) what limitations, if any, should there be on the Agency's ability 
to make available the masked data as described previously, (3) are 
there any additional factors FDA should consider in de-identifying data 
in addition to FDA's requirement to remove any names and other 
information (e.g., birth date, death date, local geographic 
information, contact information) which would identify patients or 
research subjects before disclosing information, (4) would regulatory 
changes facilitate implementation of such a proposal, and if so, what 
changes would be most useful, and (5) which situations do you believe 
disclosing masked data would be most useful to advance public health?
    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify the question your comment addresses 
by the number assigned to that question. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at https://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

    1. Hamburg, M. A. and J. M. Sharfstein, ``The FDA as a Public 
Health Agency,'' New England Journal of Medicine, 2009 June 11; 
360(24):2493-5.
    2. Chen J., J. Florian, W. Carter, et al. ``Earlier Sustained 
Virologic Response End Points for Regulatory Approval and Dose 
Selection of Hepatitis C Therapies.'' Gastroenterology, 2013 March 4 
https://www.sciencedirect.com/science/article/pii/S0016508513002886
    3. Dieterle, F., et al., ``Renal Biomarker Qualification 
Submission: A Dialog Between the FDA-EMEA and Predictive Safety 
Testing Consortium,'' Nature Biotechnology, 2010 May; 28(5):455-62.

    Dated: May 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13083 Filed 6-3-13; 8:45 am]
BILLING CODE 4160-01-P
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