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Focus on Regulation

Medical Device Alert – Political Agreement Concerning the Text of the new Regulations on medical devices and in vitro diagnostic medical devices

Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step does not constitute the official adoption of the proposed Regulations it indicates that the adoption process will soon be completed with no major changes being anticipated.

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Open Government National Action Plan aims to increase transparency in government over the course of 2016-2018

Following a Conservative manifesto commitment in 2015 to increase transparency in government, the Cabinet Office has published the UK Open Government National Action Plan 2016-2018. This is the third National Action Plan (“NAP“) since the United Kingdom co-founded the Open Government Partnership in 2011, which now includes 69 countries.

The new NAP makes 13 commitments in relation to transparency, anti-corruption and open government. In particular, the NAP aims to address certain recommendations made by the Independent Commission on Freedom of Information (the “Commission“), which published its final report in March 2016. In Commitment 8 of the NAP, the Government pledges to make plans for enhanced transparency measures, including data about senior pay and benefits for Government officials, and to update and expand the Code of Practice under s.45 of the Freedom of Information Act 2000 (“FOIA“).

Senior Government pay and benefits

While there are existing obligations in relation to the disclosure of information regarding the pay of senior Government officials, the Commission was firmly of the view that more could be done. The Commission’s report recommended greater proactive transparency about senior executive pay and benefits, which could be achieved through requiring public bodies to publish in their annual statement of accounts a breakdown of the benefits in kind and expenses of senior employees. The NAP acknowledges that information on senior pay and benefits increases transparency, and that the public should not have to resort to making information access requests under FOIA for such transparency to be achieved. The Cabinet Office intends to issue guidance to public authorities to set a higher standard for the publication of senior level pay and benefits by this summer.

 FOIA Code of Practice

The Code of Practice sets out the practice that the Government considers desirable for public bodies to follow in meeting their obligations under FOIA. However, it was issued in 2004, which was before FOIA came into force, and has not been updated since.

The Commission recommended that the government review and update the Code to take account of the ten years of operation of FOIA. An updated Code will be more useful for public authorities as it will take into account the various legal developments since 2004 that frame their FOIA obligations. In theory, this should mean that public authorities find it easier to respond to requests under FOIA.  According to the NAP, the Cabinet Office will consult on and issue a new Code of Practice by the end of this year.

An increased culture of openness?

Following the publication of the Commission’s final report we suggested that supporters of FOIA remain cautiously hopeful that FOIA will continue to work well. While the exact form of the Government’s plans is yet to be confirmed, those same supporters will continue be heartened by a commitment to implement the recommendations of the Commission over the course of this year.

Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug

On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student diagnosed with a form of brainstem cancer called Diffuse Intrinsic Pontine Glioma, was the sole participant in a Phase II study designed to enroll 10 to 40 patients for Antineoplaston therapy at the Burzynski Research Institute, Inc., in Houston, Texas.

The Fachon decision runs contrary to existing case law on patient access to investigational drugs. For example, the appellate court decision in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), cert denied 552 U.S. 1159 (2008), held that that patients have no right to “a potentially toxic drug with no proven therapeutic benefit.” The case was filed against FDA by the Abigail Alliance for Better Access to Developmental Drugs (“Abigail Alliance”), an organization formed by the father of a college student with head and neck cancer, seeking access to the experimental drug, Erbitux. At the time of the lawsuit, Erbitux was available only in clinical trials examining the efficacy and safety of the drug in colon cancer. Abigail Alliance argued that terminal cancer patients have a constitutionally protected right to access experimental medications before the FDA approves them, but the D.C. Circuit held that this theory was not embodied in the Constitution and ran contrary to the FDA regulations which permit access to experimental drugs only in limited circumstances.

As additional background, we note that the Burzynski Research Institute and its founder, Dr. Stanislaw R. Burzynski, have received FDA, Texas medical board, and media attention for decades, notably for the alleged promotion and use of unapproved cancer drugs, questionable methods, and unsafe patient practices. Notably, the Texas Medical Board filed a second amended complaint seeking to revoke Dr. Burzynski’s medical license before the Texas State Office of Administrative Hearings on September 24, 2015. The administrative action is currently ongoing.

We are monitoring the court’s docket in the Fachon litigation and will provide additional updates as the case progresses. The case is Fachon v. United States Food and Drug Admin., et al., No. 1:16-cv-00222-M-LDA (D. RI filed May 17, 2016). Continue Reading

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.

For purposes of the new Draft Guidance, EHRs are “electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.” Typical EHRs can include a patient’s medical history, radiology images, pharmacy records, and laboratory test results. The agency recognizes that EHRs may provide advantages, such as the ability to aggregate and/or analyze data from many sources or the ability to access near real-time clinical data, and that use of EHRs can, among other things, improve data accuracy and clinical trial efficacy when used properly.

Significantly, the Draft Guidance emphasizes that FDA does not intend to assess compliance of EHRs with FDA’s regulation governing electronic records (21 CFR Part 11). This is a useful clarification for drug and device companies that rely on EHRs maintained by their clinical sites. Nonetheless, FDA still intends to assess compliance with Part 11 at the point when EHR data enters the sponsor’s electronic system supporting the clinical study. For example, Part 11 obligations would be triggered once data from the EHR is entered (automatically or manually) into the electronic Case Report Form for the trial.
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Government confirms British Bill of Rights proposals will not involve leaving the ECHR

In yesterday’s Queen’s speech, the UK Government has (again) committed to publish proposals on a British Bill of Rights during the course of the next Parliamentary year. The Queen said in Parliament that:

Proposals will be brought forward for a British Bill of Rights.

Early commentary has interpreted the repetition of a commitment made in last year’s Queen’s Speech as further evidence that the Bill of Rights project has stalled as a result of disagreement among senior Government ministers about whether or not the UK should leave the European Convention on Human Rights (the “ECHR“).

However, the briefing notes accompanying the Queen’s speech, taken together with recent statements by the Attorney General, Jeremy Wright MP, and the Secretary of State for Justice, Michael Gove MP, shed some light on the Government’s current thinking.

This blog analyses the Government’s recent statements on possible reforms to the UK’s human rights framework and, in order to inform the debate, attempts to de-mystify the current legal position.

THE PROPOSALS FOR A NEW BRITISH BILL OF RIGHTS

The Conservative Party’s long-repeated intention to reform the Human Rights Act 1998 (the “HRA“) is well-documented.  Both the Conservatives’ 2010 and 2015 manifestos undertook to replace the HRA with a British Bill of Rights. The detail of a possible reform in this area has changed over time and is highly contested.

The briefing notes accompanying the Queen’s speech state, rather ambiguously, that the purpose of the Bill would be to “reform the UK human rights framework” and to “better protect against abuse of the system and misuse of human rights laws and would restore common sense to their application“.  The briefing notes also confirm that the rights “would be based on those set out in the European Convention on Human Rights, while also taking into account our common law tradition“.  This statement is contrary to recent statements by the Home Secretary, Theresa May, as to which see our recent blog post here.

When giving evidence to the House of Lords EU Select Committee on 2 February 2016, Mr Gove explained the need for the proposals.  He stated that the reasons for the reform were that “human rights… have a bad name in the public square” and that they had become associated with “unmeritorious individuals pursuing through the courts claims that do not command public support or sympathy“.  He also indicated that human rights had become a “foreign intervention” and that part of the purpose of the British Bill of Rights “is to affirm the fact that things like a prohibition on torture or a right to due process and an appropriate trial before a properly constituted tribunal… are fundamental British rights“.

As a result of Mr Gove’s evidence before it, the House of Lords EU Select Committee’s report, published on 26 April 2016, concluded that the principal motive for a British Bill of Rights was to “restore national faith in human rights, and to give human rights greater national identity, rather than to enhance human rights protection in the UK“, a proposal that the Committee considered “far less ambitious” than the one outlined in the 2015 Conservative manifesto. This led to the Committee recommending that, if it was correct that the Bill of Rights was not intended to change significantly the protection of human rights in the UK, the Government should “give careful thought before proceeding with this policy“, which would be a “constitutional change of the greatest significance“.

Mr Wright, in a statement made to the House of Commons on 26 April 2016, provided further detail on the Government’s thinking.  He indicated that the Government wished, by introducing a British Bill of Rights, to address “the expansionist approach to human rights by the Strasbourg court and under the Human Rights Act“.  He also said that, although they seek to achieve these reforms while remaining a member of the ECHR, “we will not stay at any cost… if we cannot achieve a satisfactory settlement within the ECHR, we may have no option but to consider withdrawal“.

Most recently, on 17 May 2016, Mr Gove wrote to the Chair of the Joint Committee on Human Rights, Harriet Harman MP, stating that:

The government’s position is clear and has not changed. The Bill of Rights will remain faithful to the principles in the ECHR.  Whilst we cannot rule out withdrawal from the ECHR forever, our proposals for a Bill of Rights do not involve leaving.

It is not clear whether, before the Government publishes a final proposal, these statements should be taken as a coherent indication of Government policy. However, in the light of the conclusions of the House of Lords EU Select Committee published on 26 April, the Government’s decision to include reference to the proposals for a British Bill of Rights in today’s Queen’s speech is a clear indication that it intends at least to publish its proposals shortly and put it to a public consultation.

So, assuming that the UK will remain a signatory of the ECHR, at least for the time being, how could the proposals to change the current human rights framework in the UK?

THE PROTECTION OF HUMAN RIGHTS IN THE UK: THE CURRENT POSITION

What is the ECHR and what does it do?

Signed in 1950, the ECHR is the primary source of an internationally recognised standard of legally-enforceable human rights among the 47 signatory states of the Council of Europe, of which the UK was a founding member. All signatory states are bound by international law to respect and uphold the rights provided for in the ECHR, as interpreted and enforced by the European Court of Human rights in Strasbourg.  Effectively, each signatory state has agreed to be bound by an international standard of human rights protection, against which its own domestic mechanisms for protection are judged.

The Strasbourg court is not a court of appeal in relation to the UK courts, nor can it quash or revise decisions of the UK courts. However, an alleged victim, who has exhausted their domestic remedies, can make an application against the UK in the Strasbourg court for breach of the ECHR.  The Strasbourg court can award damages against the UK and/or order the UK to rectify the breach.  The Court’s judgment is binding against the UK as a matter of international law – although not universally honoured by signatories. It has no direct, binding domestic legal effect.

The UK cannot be forced to change its laws by the Strasbourg Court or the Council of Europe. However, no doing so in the face of an adverse decision by the Court means that the UK would remain in breach of its international legal obligations under the ECHR and liable to further claims by other victims.

As long as the UK remains a signatory to the ECHR, none of the above will change without agreement of the Council of Europe and the other signatory states.

Even before the HRA provided an effective domestic remedy in the national courts, the ECHR was frequently invoked in proceedings before the UK courts and the courts became increasingly willing to have regard to the (as yet) unincorporated ECHR and the Strasbourg Court’s case law as a source of principles or standards of public policy. Therefore, if the Government were to propose a return to the pre-HRA position, this would most likely not stop the UK courts referring to ECHR jurisprudence when domestic law is ambiguous or underdeveloped.  It would, however, remove the UK courts’ power and responsibility to uphold the ECHR rights themselves, thereby preventing the UK courts from contributing to the ECHR case law by interpreting and applying the ECHR directly in the UK context.

What is the Human Rights Act and how does it protect human rights in the UK?

Since the HRA came into force in 2000, all public bodies in the UK are required, as a matter of UK law, to act in a way that is compatible with the rights set out in the ECHR. Alleged victims can bring a claim for breach of their ECHR rights against a public body in the UK courts to be decided by UK judges.  Under section 3 HRA, UK judges must interpret all legislation, so far as is possible, in a way that is compatible with the ECHR, which is incorporated into UK law by section 1 HRA.  In doing so, the UK courts are required to “take account of” the judgments of the Strasbourg court when interpreting the ECHR rights, but need not always follow them (section 2 HRA).

One criticism levelled at the UK courts by those who are in favour of repealing the HRA is that they have tended to slavishly follow the Strasbourg Court in a way that is not consistent with Parliament’s intention. In R (Animal Defenders) v Secretary of State for Culture, Media and Sport [2008] 1 AC 1312, Lord Bingham recognised that the HRA gave domestic effect to the ECHR rights and requires the courts to take into account any Strasbourg decision, but “not to follow it as a strictly binding precedent“, although he recognised that “in the absence of special circumstances our courts should follow any clear and constant jurisprudence of the Strasbourg court, recognising that the Convention is an international instrument, the correct interpretation of which can be authoritatively expounded only by the Strasbourg court“.  However, Lord Bingham also recognised that, where the judgment of Parliament appears to contradict a decision of the Strasbourg court, the judgment of Parliament should be given great weight and “should not be lightly overridden“: “A general rule means that a line must be drawn, and it is for Parliament to decide where“.

Where the UK courts do depart from clear and consistent jurisprudence of the Strasbourg Court, the unsuccessful claimant is entitled to seek a remedy from the Strasbourg court directly. This can result in a dialogue between the UK courts and the Strasbourg Court as to the correct scope of the ECHR right in question (for example, see Manchester City Council v Pinnock [2010] UKSC 45).

Where the court cannot interpret an Act of Parliament in a way that is compatible with the ECHR, it can issue a declaration of incompatibility under section 4 HRA. This declaration has no legal effect on the Act of Parliament but is a political mechanism that highlights the court’s decision to the UK Government and/or Parliament, who must then decide how to act.  This mechanism is intended to uphold the sovereignty of the UK Parliament.

The EU factor: what is the EU Charter of Fundamental Rights?

The EU is a separate organisation from the Council of Europe, established under different international agreements and for different purposes. However, the two institutions are closely linked; no country has ever joined the EU without first belonging to the Council of Europe.

The EU Charter of Fundamental Rights, which incorporates and builds on the rights set out in the ECHR, has the same legal value as the EU Treaties, thereby forming part of EU law. The Charter stipulates that when it contains rights that stem from the ECHR, the Charter adopts the meaning and scope given to such rights by the decisions of the Strasbourg Court.

As a result, the rights set out in the Charter, including the ECHR rights, are treated as general principles of EU law and are binding on all EU institutions when they exercise their functions under the EU Treaties and also on all EU member states, including (so long as it remains a member state) the UK, when they are implementing EU law into its national law. This happens in limited circumstances, such as when the member states are implementing an EU Directive.

POSSIBLE CHANGES UNDER A NEW BRITISH BILL OF RIGHTS

When it was put to him that the UK courts do not follow Strasbourg judgments as if it were a court of appeal, Mr Gove stated in his evidence to the EU Select Committee that “we cannot necessarily rely on a future court or future judges to take this approach“.

It is possible that the proposed Bill of Rights could require the UK courts to give particular weight to the judgment of Parliament when considering whether an Act of Parliament is incompatible with the ECHR, thereby giving a statutory footing to this principle. However, as explained above, the courts already do this, so such a change is unlikely to make much practical difference.

Mr Gove also considered whether the proposed reforms could put the UK in breach of its legal obligations under the ECHR. He stated that “it could be a problem” but that the Government was “not planning to derogate absolutely from any of the rights [in the ECHR]. At the moment we envisage that all the rights contained within the Convention will be affirmed in any British Bill of Rights, but where rights are subject to potential qualification, we may emphasise the importance of one right over another“.

In the event that the Bill of Rights did derogate from the rights protected in the ECHR, as interpreted by the Strasbourg Court, this could clearly result in more applications against the UK in Strasbourg. However, perhaps more significantly, it could also result in more challenges under the EU Charter of Fundamental Rights in the UK courts.  The power of the UK courts when applying the EU Charter to disapply a provision of national legislation (even an Act of Parliament) that is inconsistent with the EU Charter is a more effective remedy than a declaration of incompatibility under section 4 HRA.  Such challenges could also result in more references by the UK courts to the Court of Justice of the European Union for authoritative interpretations of EU law, which, unlike decisions of the Strasbourg Court, the UK courts would be bound to follow.

Therefore, if the UK votes to remain in the EU on 23 June 2016, introducing a British Bill of Rights with the intention of giving human rights a greater national identity but in a manner that diminishes protection of the ECHR in the national courts could lead to more challenges to UK legislation in the EU courts on the grounds that it breaches international human rights standards.

Reform to the current framework also raises questions about the devolution settlement within the UK. There are already signs of the difficult political path ahead for any successful adoption of a new British Bill of Rights.  The Irish Government wrote to Mr Gove on 3 February 2016 emphasising that, under the Good Friday Agreement, the ECHR must be incorporated into the law of Northern Ireland, including the right to direct access to the courts, remedies for breach of the ECHR and the power for the courts to overrule legislation enacted by the Northern Irish Assembly on the basis that it is incompatible with the ECHR.  The Scottish Government has also publicly stated that it would resist reforms to the Scotland Act that would result in the ECHR not being incorporated into Scottish law.  As the EU Select Committee pointed out, if such resistance proves insurmountable, it could result in the British Bill of Rights ending up as an “English Bill of Rights“.

CONCLUSION

The Queen’s speech does not give much away in terms of the substantive content of the Government’s proposal for a new British Bill of Rights. However, given that the Government’s plans are so controversial, with both sides of the debate passionate and vocal in their belief that the other side is dangerously wrong, it is very unlikely that any conceivable proposal could satisfy everyone.  In fact, it is more likely that the Government’s current trajectory, namely to remain within the ECHR but tinker around the edges of the current domestic framework for human rights, could end up satisfying no one.

Equality and Human Rights Commission publishes helpful new human rights guidance for businesses

The Equality and Human Rights Commission recently published new guidance that outlines, in a practical and accessible way, how company boards can ensure that their companies meet UK and international expectations and obligations in relation to human rights.  The guidance is intended to make it easier for company directors to know whether their businesses are doing what they should to meet their human rights responsibilities.

There is an increasing focus on human rights in the business sphere, both in the UK and globally.  Businesses in the UK are already subject to various human rights obligations under UK and EU law as well as the international, voluntary standards imposed by the UN Guiding Principles on Business and Human Rights. Companies are increasingly conscious of their obligations in this regard and many have recognised the commercial opportunities that a good track record on human rights compliance can bring.

The Equality and Human Rights Commission, whose role is to safeguard people’s rights under equality legislation, examines in its guidance the interaction between business and human rights and sets out five concrete steps that it suggests all company boards should follow to ensure that their business complies with domestic and international human rights obligations.  In summary, they propose that companies should:

1) embed the responsibility to respect human rights into their culture, knowledge and practices;

2) identify risks to human rights through e.g. their business models and relationships;

3) systematically address those risks through e.g. their commercial influence and action with business peers;

4) engage with stakeholders to inform their approach to addressing human rights risks; and

5) meet reporting requirements in relation to human rights by publicly explaining how they satisfy their commitment to respect human rights.

The guidance also includes various practical questions that directors can consider to guide discussions with senior management about relevant human rights issues.

Although the guidance is not particularly ground-breaking, it provides a useful “road map” to human rights compliance.  The guidance also shows how public bodies are increasingly acknowledging the vital role of the private sector in upholding the rule of law and human rights. It is clear that, in publishing this guidance, the Commission is giving companies a real push to commit to, and take responsibility for, human rights compliance in their businesses and that there is more work to be done.

(To find out more about the benefits that effective human rights compliance can bring, see our recap of a panel discussion held by Hogan Lovells’ Business and Human Rights Practice here).

Drones on Campus: FAA Opens Door to Expanded Student Drone Use in the Classroom

Source: http://dailycollegelife.com

Image Source: dailycollegelife.com

Colleges and universities across the country are finding new and innovative ways to use drones in the classroom.  To name just a few, institutions of higher education are using drones to support research and learning in areas like precision agriculture, wildlife habitat monitoring, and aerial surveying and mapping.

While speaking at the AUVSI annual conference in New Orleans this morning, FAA Administrator Michael Huerta announced the release of a new Legal Interpretation that will expand the scope of permissible UAS operations by students and educational institutions.  The FAA’s principal conclusions are:

  1. A person may operate an unmanned aircraft under the carve-out for hobbyist operators in Section 336 of the FAA Modernization and Reform Act of 2012 (FMRA) at educational institutions and community-sponsored events provided that the person is (a) not compensated or (b) any compensation received is neither directly nor incidentally related to that person’s operation of the aircraft at such events.
  2. A student may conduct model aircraft operations in accordance with section 336 of the FMRA in furtherance of his or her aviation-related education at an accredited educational institution.
  3. Faculty teaching aviation-related courses at accredited educational institutions may assist students who are operating a model aircraft under section 336 and in connection with a course that requires such operations, provided that the student maintains operational control of the model aircraft such that the faculty member’s manipulation of the model aircraft’s controls is incidental and secondary to the student’s.

The FAA cautioned that a faculty member engaging in the operation of an unmanned aircraft, as part of professional duties for which he or she is paid, would not be engaging in a hobby or recreational activity.  Similarly, a student operating UAS for research on behalf of a faculty member is associated with the faculty member’s professional duties and compensation and, thus, is not hobby or recreational use by the student pursuant to section 336.  Faculty and students in these situations would need to seek and obtain authorization from the FAA.

The FAA also concluded, however, that limited instructor involvement in student operation of UAS as part of coursework does not automatically make the flight non-hobbyist or commercial in nature. This would include courses at accredited institutions where the operation of the unmanned aircraft is not the primary purpose of the course (for example, using drones as part of an agricultural science class).  This exception for limited instructor involvement would not extend to classroom courses where the primary purpose of the class is UAS flight instruction.

While the new Legal Interpretation won’t eliminate the need to seek and obtain authorization from the FAA for all UAS flight activities at educational institutions, the announcement is welcome news and a step in the right direction for expanding drone use in academia.

EU Referendum: English High Court refuses British expats’ application for judicial review of “15 year rule”

The High Court has rejected a legal challenge to legislation excluding British citizens who have lived abroad for more than 15 years from voting in the EU Referendum.

The British expat Claimants, who had lived in other EU member states for over 15 years, claimed that the EU Referendum Act 2015 breached their rights to free movement under EU law.

The High Court held that:

  • section 2 of the Act, which adopts the 15-year rule, was capable of engaging EU law;
  • the 15 year rule was not a restriction on the Claimants’ rights of free movement as EU citizens: it was “totally unrealistic to suggest that this rule could have the effect of deterring or discouraging anyone considering whether to settle or remain in another Member State”; and
  • even if the 15 year rule were a restriction on those rights, it would be objectively justified because Parliament could “legitimately take the view that electors who satisfy the test of closeness of connection set by the 15 year rule form an appropriate group to vote” on the question posed in the EU referendum. In addition, there would be “significant practical difficulties” in adopting a new electoral register because, by way of example, current practice is for electoral registers to be retained for 15 years, meaning that there would be no straightforward means of checking the previous residency status of British citizens currently subject to the 15-year rule.

The High Court granted the Claimants permission to appeal to the Court of Appeal. The Claimants are expected to pursue an expedited hearing, which could result in the appeal being heard in the next two to three weeks. In principle, the threat to the EU referendum date therefore remains.

Big News: Small UAS Rule at OIRA for Final Review

In a major new development, the FAA has sent the Small UAS NPRM to the White House for a final interagency review.  This means that a final small UAS rule is coming soon – and that NOW is the last opportunity to influence the rule before it is released.

Before any significant regulatory action takes effect, it first must go through a review process at the Office of Information and Regulatory Affairs (OIRA) at the White House.  OIRA is located within the Office of Management and Budget (OMB) within the Executive Office of the President.  It is commonly said that OIRA is the most important agency in Washington, DC that nobody has heard of.  OIRA reviews draft regulations before they are implemented and reviews and evaluates cost/benefit analyses to determine whether the benefits of a rule would justify the costs.

We are now at an extremely important step in the rulemaking process, which provides industry stakeholders with one final opportunity to provide additional input before the final rule is released.

The period for OIRA review is limited by Executive Order 12866 to 90 days.  Under the Executive Order, the review period may be extended indefinitely by the head of the rulemaking agency; alternatively, the OMB Director may extend the review period on a one-time basis for no more than 30 days.  According to OIRA, the average review period is 53 days.  OIRA received the FAA’s Small UAS NPRM for review on April 20, 2016.

As part of its review process, any member of the public—including UAS manufacturers, operators, and users—can request a meeting with the agency to discuss the proposed rule, what it should contain, and how the rule will impact them. The meetings are conducted by the OIRA Administrator or his designees, and a log of all meetings is publicly available.

A meeting with OIRA provides a golden opportunity for stakeholders to make their voices heard on key UAS policy issues.  Companies that want to provide input on issues such as certification of pilots and visual observers, registration of UAS, approval of operations, federal preemption of UAS policy issues, and operational limits for UAS now have the chance to provide their ideas directly to the White House.  It is also helpful for stakeholders to reinforce the importance of expediency in moving the rulemaking forward.

If you would like to communicate your views to the White House during this review period, let us know. We would be happy to help.