Section III: Steps Taken to Increase Proactive Disclosures

The Department of Justice has long focused on the need for agencies to work proactively to post information online without waiting for individual requests to be received.

Please answer the following questions to describe the steps your agency has taken to increase the amount of material that is available on your agency websites. In addition to the questions below, you should also describe any additional steps taken by your agency to make and improve proactive disclosures of information.

1. Provide examples of material that your agency has proactively disclosed during the past reporting year, including links to the posted material.

HHS continues to employ a number of ways to identify records for online public disclosure. HHS OpDivs use the established threshold of three requests for the same information to identify records of substantial public interest, either by reviewing FOIA logs, manually tracking FOIA requests or from identifying requests for the same records from an electronic tracking system. In addition, information is gathered from program areas and offices about significant policy documents that may be candidates for proactive disclosure, and public affairs and communications staff provide input and suggestions for records they believe should be proactively disclosed to the public.

Please see the examples, listed below, of material that HHS has proactively disclosed during FY 2017.

  • HHS became the first Executive Branch entity to publish open/pending initial request data to the HHS FOIA website which the ASPA FOIA Division has updated on a quarterly basis throughout the year. The data provide a point in time forecast of future production performance by the HHS FOIA offices and enables the HHS OpDivs to identify and accurately assess the status of all open, pending requests and appropriately focus Department-wide resources and processing efforts:

https://www.hhs.gov/foia/reports/pending/2017/index.html

  • CMS has proactively disclosed the following information:
  • Frequently requested Public Use Files related to Marketplace enrollment:

https://www.cms.gov/CCIIO/Resources/Data-Resources/marketplace-puf.html

  • CMS Medicare beneficiary chronic conditions data dashboards:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CCDashboard.html

  • Data showing payments from drug and device companies to physicians and teaching hospitals for things like travel, research, gifts, speaking fees, meals; as well as any ownership interests that physicians or their immediate family members have in these companies:

https://www.cms.gov/openpayments/

  • Medicare Part D opioid prescribing mapping interactive tool shows geographic comparisons, at the state, county, and ZIP code levels:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/OpioidMap.html

  • New information posted for the public and beneficiaries regarding CMS’s initiative to issue new Medicare cards that no longer contain patient Social Security Numbers:

https://www.cms.gov/medicare/new-medicare-card/nmc-home.html

  • FDA has proactively disclosed the following information:
  • FAERs public dashboard, an interactive web-based tool that allows for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers. See https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm070093.htm.
  • Data sets, such as http://govdashboard.fda.gov/, which relate to inspections, compliance and recalls. This dynamic online tool presents information in an easy-to-read graphical format. It provides access to the underlying data, allowing the public to see related data and trends. Users can also view, download and manipulate the data.
  • Agency components continue to create web pages for specific issues of heightened consumer or media interest, to better inform the Agency’s constituency without requiring the submission of a FOIA request. For example, FDA has posted extensive information in the reporting period on such subjects as:

Drug compounding:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm384667.htm

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm431393.htm

http://www.fda.gov/aboutfda/centersoffices/officeofglobalregulatoryoperationsandpolicy/ora/oraelectronicreadingroom/ucm466693.htm

Food Safety http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Compounding Pharmacy Inspections http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm384667.htm

Use of Antimicrobials in Veterinary Practice http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/default.htm

Dietary Supplements http://www.fda.gov/aboutfda/transparency/basics/ucm193949.htm

Deeming of Tobacco Products http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm

Flu Vaccine http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm454877.htm

  • FDA also continues to post the following records on a regular basis, among others:

Weekly Enforcement reports http://www.fda.gov/safety/recalls/enforcementreports/default.htm

Recall information (http://www.fda.gov/Safety/Recalls/default.htm

Advisory Committee packages and transcripts http://www.fda.gov/advisorycommittees/default.htm

Budget records http://www.fda.gov/newsevents/testimony/ucm522392.htm

Import Refusals http://www.fda.gov/forindustry/importprogram/importrefusals/default.htm

International Arrangements http://www.fda.gov/internationalprograms/agreements/default.htm

Press Releases http://www.fda.gov/newsevents/newsroom/pressannouncements/default.htm

Tobacco Retailer Warning Letters http://www.fda.gov/iceci/enforcementactions/warningletters/tobacco/default.htm

Clinical Investigator Correspondence http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings

Warning Letters and responses http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Inspection records and firm responses http://www.fda.gov/aboutfda/centersoffices/officeofglobalregulatoryoperationsandpolicy/ora/oraelectronicreadingroom/default.htm

Inspection databases http://www.fda.gov/iceci/inspections/ucm222557.htm

FDA Track Updates (which includes tracking of FOIA metrics) http://www.fda.gov/aboutfda/transparency/track/default.htm

Post-Approval studies http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm

Consumer Advisories and Alerts for blood products and vaccines http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/default.htm

  • HRSA has proactively disclosed the Uniform Data System (UDS) reports. These reports are submitted annual by Federally Qualified Community Health Centers (FQHCs) funded by HRSA, and consist of 14 highly-detailed tables that provide a standardized means of measuring a health center’s performance on an annual basis.
    https://bphc.hrsa.gov/datareporting/reporting/index.html
  • NIH has proactively disclosed the following information:
  • FOIA Logs

https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office/nih-foia-log

  • Procurement-Related Information

https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office/nih-procurements-purchases

  • IC Directors Meetings Highlights

https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office/selected-nih-ic-directors-meeting-highlights

  • Unpaid NIH FOIA Invoices

http://employees.nih.gov/pages/ocpl/foia/Requester.pdf

http://employees.nih.gov/pages/ocpl/foia/Organization.pdf

  • CSR Peer Review Notes

https://www.csr.nih.gov/CSRPRP/2017/09/interview-with-dr-mike-lauer-director-nih-office-of-extramural-research/

http://public.csr.nih.gov/RosterAndMeetings/Pages/default.aspx

http://www.fic.nih.gov/News/

http://www.fic.nih.gov/Grants/Search/Pages/search-grants.aspx

  • Funded activities under the NCATS Clinical and Translational Science Awards (CTSA) Program

https://ncats.nih.gov/files/ctsa-funding-information.pdf

  • NCATS Strategic Plan

https://ncats.nih.gov/strategicplan

  • NCATS Toolkit for Patient-Focused Therapy Development

https://ncats.nih.gov/toolkit

  • Pre-Clinical Research Toolbox

https://ncats.nih.gov/expertise/preclinical

  • Clinical Research Toolbox

https://ncats.nih.gov/expertise/clinical

  • Licensing opportunities

https://ncats.nih.gov/alliances/licensing

  • NCATS Funding & Notices

https://ncats.nih.gov/funding

  • NCATS Releases and Announcements

https://ncats.nih.gov/news/releases

  • Budget and Congressional Justification

https://ncats.nih.gov/about/center/budget

https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/implementation

  • October 20, 2016 and January 19, 2017 National Advisory Eye Council (NAEC)

http://www.nlm.nih.gov/socialmedia/index.html

https://www.nhlbi.nih.gov/health/health-topics/topics/sca

  • Pneumonia

https://www.nhlbi.nih.gov/health/health-topics/topics/pnu

  • LAM

https://www.nhlbi.nih.gov/health/health-topics/topics/lam

  • COPD (English and Spanish)

https://www.nhlbi.nih.gov/health/health-topics/topics/copd

https://www.nhlbi.nih.gov/health-spanish/health-topics/temas/copd

  • High Blood Pressure (English and Spanish)

https://www.nhlbi.nih.gov/health/health-topics/topics/hbp

https://www.nhlbi.nih.gov/health/health-topics/topics/heart-healthy-lifestyle-changes

https://www.nhlbi.nih.gov/health-spanish/health-topics/temas/cambios-en-el-estilo-de-vida-saludables-para-el-coraz%C3%B3n

  • CPAP

https://www.nhlbi.nih.gov/health/health-topics/topics/cpap

  • Sleep Studies

https://www.nhlbi.nih.gov/health/health-topics/topics/slpst

  • Oxygen Therapy

https://www.nhlbi.nih.gov/health/health-topics/topics/oxt

http://www.nhlbi.nih.gov/news/press-releases/

http://www.niaaa.nih.gov/about-niaaa/advisory-council

  • News Releases

https://www.niaid.nih.gov/news-events/newsroom

  • News from our Grantees

https://www.niaid.nih.gov/news-events/niaid-funded-research-news

  • Electron microscopy data bank

http://www.emdatabank.org

https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE77656

  • NIBIB-funded science highlights

http://www.nibib.nih.gov/news-events/newsroom

  • Funding opportunities

http://www.nibib.nih.gov/research-funding#quicktabs-funding_tabs=1

http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html

https://loop.nigms.nih.gov/2017/04/a‐historical‐analysis‐of‐nigms‐early‐stage‐investigators-awardsand-funding/

https://www.nimh.nih.gov/news/science-news/2017/nimh-releases-strategic-research-priorities-update.shtml

  • Narcolepsy fact sheet in English (also prepared in e-Pub formats)

https://catalog.ninds.nih.gov/ninds/facet/Health-Topics/term/Narcolepsy

  • Restless Legs Syndrome fact sheet in English (also prepared in e-Pub formats)

https://catalog.ninds.nih.gov/ninds/facet/Health-Topics/term/Restless-Legs-Syndrome

http://www.nlm.nih.gov/socialmedia/index.html

2. Did your agency use any means to publicize or highlight important proactive disclosures for public awareness? If yes, please describe these efforts.

The Department continues to actively use Facebook, Twitter, YouTube, Flickr, Pinterest and GooglePlus to communicate and disseminate information to the public. Some examples of HHS OpDiv initiatives are described below:

  • CMS has continued to utilize press releases and other existing outreach programs to let interested parties know when information has been proactively disclosed. Press materials and webpages are often structured around high-interest programs to share information.
  • OIG uses a subscriber service to announce daily updates and important disclosures on its website.
  • FDA uses social media, including Facebook and Twitter, posts high priority public information on the homepage of the agency website, uses a subscriber service for updates, and the Commissioner writes a blog on high visibility issues.
  • IHS posts information on the agency homepage.
  • NIH uses Facebook, Twitter, YouTube, Flicker, Google+, and Tumblr, in addition to E-newsletter’s and print publications.

3. Beyond posting new material, is your agency taking steps to make the posted information more useful to the public, especially to the community of individuals who regularly access your agency’s website?

Yes. HHS continues its efforts to make more information available through mobile applications and increase its presence in social media; thereby expanding access to more useful information and data. In addition, the Department’s FOIA Offices continue to make their online content and navigation tools more user-friendly.

4. If yes, please provide examples of such improvements.

  • CMS is designing an interface to the “Blue Button API” to enable Medicare beneficiaries to connect their healthcare data to third-party applications they trust; putting the beneficiary in control of their own health data records. This improvement is more useful to the public, as approximately 80% of the FOIA requests received by CMS relate to beneficiary records.
  • FDA is currently engaged in a redesign of its website, which should be completed in early 2018. FDA also has a mobile-friendly website, and makes many of its webpages available through subscriptions, which allows the public to receive automatic notifications by email when new Warning Letters are posted to the FDA website.
  • IHS- Program Offices update new health initiatives or services for American Indians/Alaskan Natives on their homepage.
  • NIH has translated materials into many different languages, and also provides some information in multiple formats, such as Excel and Adobe PDF.
  • OIG uses Twitter, YouTube, Podcasts and Widgets to help ensure usability and access to its website.

5. If there are any other steps your agency has taken to improve proactive disclosures, please describe them here. For example, has your agency engaged requesters in determining how and what to post? Has your agency used web analytics to inform your proactive disclosures?

The HHS FOIA Offices continue to work with requesters to explore new and improved ways to post online information. Some examples of these actions are described below:

  • CMS worked quickly to gather and complete the disclosure analysis on a very voluminous set of records in response to multiple requests for correspondence records between CMS and Representative Tom Price prior to his congressional nomination hearing for HHS Secretary. These records were cataloged, organized and posted online for the public at https://www.hhs.gov/foia/transition.html. Furthermore, in response to frequent annual requests for data related to Marketplace enrollment numbers for each new plan year, CMS is collecting and summarizing data into “weekly snapshots” that are posted on the CMS website to provide the public with a clear overview of enrollment numbers by state.
  • IHS currently works with IT staff to develop proactive disclosures.

NIH Office of Extramural Research provides information tools about grants on their website listed at https://report.nih.gov/. The Office of Extramural Research also offers NIH Regional Seminars on Program Funding and Grants Administration. In 2017, those meetings were in New Orleans (May 3-5, 2017) and Chicago, IL (October 26-28, 2017). These seminars are an educational opportunity to help PIs understand the fundamentals of the NIH grants process, including the electronic application process, award management, NIH peer review, finding the right funding opportunity, federal research policies, and pre-and post-award issues. These seminars provide an opportunity for feedback on the data that has been posted on the website.

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