SUPPORTING STATEMENT FOR
MEDICAL DEVICES; HUMANITARIAN USE DEVICES
21 CFR Part 814 – Subpart H
A. Justification
Circumstances Necessitating Information Collection
The Food and Drug Administration (FDA) is requesting Office of Management and Budget (OMB) approval of the requirements set forth in this information collection. This collection enforces the requirements of 21 CFR Part 814, Subpart H (Attachment A) and the Final Rule published in the November 3, 1998, Federal Register.
The purpose of the regulation is to implement the humanitarian use device (HUD) provision of the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) and its amended rule (21 CFR 814 Subpart H). The HUD provision has been incorporated into section 520(m) (21 U.S.C. 360j(m)) of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). Under section 520(m) of the act, FDA is authorized to exempt a HUD from the effectiveness requirements in sections 514 and 515 of the act (21 U.S.C. 360d and 360e) provided that the device (1) is used to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States; (2) would not be available to a person with such a disease or condition unless the exemption is granted, and there is no comparable device, other than another HUD approved under this exemption, available to treat or diagnose the disease or condition; and (3) the device will not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health from using the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Section 203 of FDAMA made several changes to section 520(m) of the act, and implements the amendments to the HUD provision mandated by FDAMA.
FDA is requesting Office of Management and Budget (OMB) approval for the collection of information required by the amendments to 21 CFR 814 promulgated under the statutory mandate of section 520(m) of the act, as amended by FDAMA.
Section 814.102 – Reporting
Prior to submitting an HDE application, the applicant shall submit a request for HUD designation to FDA's Office of Orphan Products Development.
Section 814.104 – Reporting
After receiving a HUD designation, the applicant shall submit an HDE application to FDA.
.
Section 814.106 – Reporting
An HDE applicant may amend a pending HDE or HDE supplement to revise existing information or provide additional information.
Section 814.108 – Reporting
After FDA approval of an original HDE, the holder shall submit supplements for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the holder has an approved HDE, unless the change is of a type for which FDA has advised that an alternate submission is permitted.
Section 814.116(e)(3)
The applicant must submit a written notice to FDA that the HDE has been withdrawn.
This section allows physicians in an emergency situation to administer a HUD prior to obtaining Institutional Review Board (IRB) approval. In such a situation, the physician is required to provide written notification to the IRB within 5 days after emergency use.
Section 814.124(b) – Reporting
A holder of an approved HDE shall notify FDA of any withdrawal of approval for the use of a HUD by a reviewing IRB within 5 working days after receipt of the withdrawal of approval.
Section 814.126(b)(1) – Reporting
The holder of an approved HDE shall submit a periodic report to demonstrate continued compliance with the humanitarian device exemption (HDE) requirements.
An HDE holder shall maintain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRBs as well as any other information requested by a reviewing IRB or FDA. Such records shall be maintained in accordance with the HDE approval order.
2. How, by Whom, and for What Purpose Information Used
The information gathered by this collection enables FDA to determine whether an HDE holder is in compliance with the HDE requirements. It will also allow FDA to determine whether to: (1) grant HUD designation of a medical device; (2) exempt a HUD from the effectiveness requirements in sections 514 and 515 of the act (21 U.S.C. 360d and 360e) provided that the device meets requirements set forth in section 520(m) of the act; and (3) grant marketing approval(s) for the HUD. Failure to collect this information would prevent FDA from making that determination.
3. Consideration of Information Technology
There are no technical or legal obstacles to the collection of this information. Data regarding pediatric populations or pediatric subpopulations are to be included in the original HDE application under 21 CFR 814.104. FDA accepts and encourages the submission of electronic copies from any manufacturer that wishes to submit an electronic copy with a premarket submission. (See CDRH's website at http://www.fda.gov/cdrh/elecsub.html.)
To date, the use of electronic forms of recordkeeping and submissions to FDA remains voluntary.
4. Efforts to Identify Duplication and Similar Information Already Available
FDA believes that the information being collected will not duplicate information already available. A HUD sponsor will be provided with the opportunity to obtain marketing clearance through the HDE application procedures instead of through either the premarket notification procedures or the premarket approval application procedures.
Small Business
This information collection will not have a significant economic impact on a substantial number of small entities. While the number of HDE applications FDA will approve is unknown, FDA believes that it will approve approximately 6 HDE applications per year. Moreover, submission of HDE applications is entirely voluntary. Respondents who believe that it will not be in their business’s interest to submit an HDE application will be unlikely to do so. Moreover, the HDE regulation helps small businesses by exempting them from the requirement for full PMAs. Furthermore, section 814.104(b)(5) minimizes the burden on all entities by allowing a responsible individual of the HDE holder's organization to submit an attestation regarding the charges, in lieu of a CPA for which the organization would be compelled to pay.
6. Consequences of Less Frequent Information Collection and Technical or Legal Obstacles
This information is necessary to FDA to determine whether a device is eligible for HUD designation and thus exempted from the effectiveness requirements of Sections 514 and 515 of the act (21 U.S.C. 360d and 360e). It is also necessary to determine whether an HDE holder is in compliance with the HDE requirements (sections 510(m)(3) and (5)) of the act.
If FDA did not receive information from potential HUD applicants, FDA would have no basis for granting HUD exemptions. The frequency of FDA's receipt of HDE applications will be determined by the frequency with which applicants submit HDE applications. This frequency cannot be reduced without unnecessarily delaying marketing clearance decisions under section 520(m) of the act.
Consistency With the Guidelines in 5 CFR 1320.6
This collection of information is consistent with the guidelines prescribed in 5 CFR 1320.6.
Consultation Outside the Agency
Notice was published on October 1, 2008, in the Federal Register on update soliciting comments on this information collection prior to its submission to the Office of Management and Budget (OMB) as required by 5 CFR 1320.8(d) ( Attachment D). No comments were received regarding the information collection.
Payment or Gifts to Respondents
FDA will not provide payment or gifts to sponsors under the HUD provisions.
Confidentiality of Information
Section 814.122(a) states that any record in the HDE file, including all data and information submitted with or incorporated by reference into the HDE, any HDE supplement, any report under §814.126, any master file, or any other related submission, will be available for public disclosure in accordance with the restrictions and conditions available to PMA files under §814.9(b) through (h), the public information regulations at 21 CFR part 20, and any other applicable regulation governing confidentiality of information or public disclosure of information. The confidentiality of information is not affected by the amendments.
Sensitive Questions
The information collected does not include questions pertaining to sexual behavior, attitude, religious beliefs, or any other matters that are commonly considered private or sensitive in nature.
12. Estimates of Burden Hours and Explanation
FDA estimates the burden for this information collection as follows:
Table 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Re‑ sponses |
Hours per Response |
Total Hours |
814.102 |
14 |
1 |
14 |
40 |
560 |
814.104 |
6 |
1 |
6 |
320 |
1,920 |
814.106 |
6 |
2 |
12 |
50 |
600 |
814.108 |
32 |
1 |
32 |
80 |
2,560 |
814.116(e)(3) |
1 |
1 |
1 |
1 |
1 |
814.124(a) |
5 |
1 |
5 |
1 |
5 |
814.24(b) |
4 |
1 |
4 |
2 |
8 |
814.126(b)(1) |
45 |
1 |
45 |
120 |
5,400 |
Total 11,054
1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section |
No. of Recordkeeper |
Annual Frequency per Recordkeeping |
Total Annual Records |
Hours per Record |
Total Hours |
814.126(b)(2) |
45 |
1 |
45 |
2 |
90 |
Total 90
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Cost to Respondents
Multiplying the total reporting and recordkeeping hours (11,144) by an average rate of $50 per hour, yields an estimate annual cost to respondents of $557,200.
13. Annualized Cost to Respondents
There are no capital costs or operating and maintenance costs associated with this collection.
14. Annual Cost to the Government
FDA estimates that 22.5 full time equivalent (FTE) positions will be required to fully implement the collection of information and response to applicants and holders required as a result of the requirements of section 520(m) of the act and the implementing regulation. These positions are expected to cost the government about $2,704,080 on average, based on the mix of staff expertise required to implement the HUD. The positions range from GS-5 clerical personnel to GS-15 medical officers; and the average cost for each position is $118,600 ($113,600 for personnel costs and benefits and $5,000 of operating funds per year at a total cost of $118,600 for each full time position).
15. Changes in Burden
The burden represented by this collection of information has increased by 1,106 hours since the last time OMB approved this information collection. This increase in burden can be attributed to an alteration of the number of anticipated responses to CFR §§814.108 and 814.126(b)(1). Additionally, recordkeeping has increased due to a boost in the number of anticipated HDE holders that need maintain certain information under §814.126(b)(2).
16. Statistical Reporting
FDA does not intend to publish the results of this information collection.
17. Exemption for Display of Expiration Date
No exemption approval is requested.
18. Exemption to Certification Statement
There are no exemptions to the certification statement identified in Item 19 of OMB Form 83-I.
The use of statistical methods is not applicable.
| File Type | application/msword |
| File Title | Extension 0332 SS 2008 |
| Subject | ICR Extension for HDE Regulation |
| Author | Terri T. Garvin |
| Last Modified By | DPresley |
| File Modified | 2008-12-05 |
| File Created | 2008-12-02 |