Contains Nonbinding Recommendations  
Recognition and Withdrawal of 
Voluntary Consensus Standards 
 
Guidance for Industry and  
Food and Drug Administration Staff  
Document issued on September 15, 2020.   
The draft of this document was issued on September 14, 2018. 
 
This document supersedes CDRH Standard Operating Procedures for the 
Identification and Evaluation of Candidate Consensus Standard for 
Recognition, issued on September 17, 2007. 
 
 
For questions about this document, contact the Office of Strategic Partnerships and Technology 
Innovation (OST) at (301) 796-5600 or the Standards and Conformity Assessment Program by 
e-mail at CDRHStandardsStaff@fda.hhs.gov.  
 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.  
 
 
OMB Control No. 0910-0120 
Current expiration date available at https://www.reginfo.gov 
See additional PRA statement in Section VII of this guidance 
 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Devices and Radiological Health  
Center for Biologics Evaluation and Research  
 
 
  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency 
consideration to https://www.regulations.gov.  Submit written comments to the Dockets 
Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-
305), Rockville, MD 20852.  Identify all comments with the docket number FDA-2018-D-
2936. Comments may not be acted upon by the Agency until the document is next revised 
or updated. 
Additional Copies 
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 616 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research 
(CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New 
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-
4709 or 240-402-8010, by email, ocod@fda.hhs.gov, or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-
information-biologics/biologics-guidances.   Contains Nonbinding Recommendations 
Table of Contents 
I. Introduction ................................................................................................................................. 1 
II. Background ................................................................................................................................ 1 
III. Scope ......................................................................................................................................... 2 
IV. FDA Recognition of Standards ................................................................................................. 2 
A.   Recognition ...................................................................................................................... 4 
B.   Requesting Recognition ................................................................................................... 5 
C.   Extent of Recognition: Complete or Partial Recognition ................................................. 6 
D.   Non-Recognition .............................................................................................................. 6 
E.   Notification of Determination .......................................................................................... 7 
V. Supplementary Information ....................................................................................................... 7 
A.   Essential Information Provided ........................................................................................ 7 
B.   Scope ................................................................................................................................ 8 
C.   FDA Decision Making Rationale ..................................................................................... 8 
VI. Withdrawal of Recognition ....................................................................................................... 8 
A.  FDA-Recognized Consensus Standard Replaced by New Version ................................. 8 
B.  FDA-Recognized Consensus Standard no longer appropriate for meeting a 
requirement ............................................................................................................................... 9 
VII. Paperwork Reduction Act of 1995 .......................................................................................... 9  Contains Nonbinding Recommendations 
Recognition and Withdrawal of 
Voluntary Consensus Standards 
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction 
The Food and Drug Administration (FDA) developed this document to provide guidance to 
industry and FDA staff about the procedures the Center for Devices and Radiological Health 
(CDRH) follows when we receive a request for recognition of a voluntary consensus standard for 
medical products.1 The guidance outlines principles for recognizing a standard wholly, partly, or 
not at all, as well as reasons and rationales for withdrawing a standard. 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.2   
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
II. Background 
Congress enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115) and the 21st Century Cures Act (Pub. L. 114-255). These acts amended the 
                                                
1 All requests for recognition of a voluntary consensus standard for medical devices are managed by CDRH, 
including any requests for recognition of a standard that would apply to a device regulated by CBER. In this 
guidance, product refers to medical devices including those that are licensed as biological products under section 
351 of the Public Health Service (PHS) Act. 
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
1  Contains Nonbinding Recommendations 
Federal Food, Drug, and Cosmetic Act (FD&C Act) by amending section 514(c), 21 U.S.C. 
360d(c), regarding the recognition of standards. 
The term recognize in section 514(c) of the FD&C Act refers to FDAs identification of 
standards as appropriate for manufacturers of products to declare conformance to meet relevant 
requirements under the FD&C Act, including premarket submission requirements. This guidance 
refers to voluntary consensus standards recognized by FDA in the Federal Register in 
accordance with section 514(c) of the FD&C Act as FDA-recognized consensus standards. 
CDRHs Standards and Conformity Assessment Program (S-CAP) furthers the aim of 
international harmonization because the same standards (or international equivalents) are relied 
upon by sponsors to meet other countries regulatory requirements when appropriate. For 
example, adherence to such standards is an optional method of meeting the General Safety and 
Performance Requirements (GSPR) under the European Medical Device Regulation (EU 
MDR). 
III. Scope 
This guidance describes the procedures that FDA follows, and the actions FDA may take during 
its review and evaluation of requests for standards recognition or the withdrawal of recognition. 
This guidance provides further clarity and explanation about the regulatory framework, policies, 
and practices regarding FDAs recognition and withdrawal of recognition of voluntary consensus 
standards. 
IV. FDA Recognition of Standards 
The Agency recognizes voluntary consensus standards to help facilitate meeting requirements 
under the statute or regulations. The use of FDA-recognized consensus standards can increase 
predictability, streamline premarket review, provide clearer regulatory expectations, facilitate 
market entry for safe and effective medical products, and promote international harmonization. 
FDA considers for recognition voluntary consensus standards, i.e., standards that are developed 
by voluntary consensus standards bodies. These bodies are defined as any organization that 
plans, develops, establishes, or coordinates standards using a voluntary consensus standards 
development process that includes the attributes or elements outlined in the OMB Circular A- 
119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in 
Conformity Assessment Activities.3 We believe these attributes or elements help ensure that 
standards recognized by FDA are fair and relevant and useful for regulatory purposes. This in 
turn encourages their use by manufacturers and advances opportunities for national and 
international harmonization. Specifically, these attributes or elements are: 
1.  Openness. The procedures or processes used are open to interested parties. Such parties 
are provided meaningful opportunities to participate in standards development on a non-
                                                
3 https://www.nist.gov/system/files/revised_circular_a-119_as_of_01-22-2016.pdf 
2 Contains Nonbinding Recommendations 
discriminatory basis. The procedures or processes for participating in standards 
development and for developing the standard are transparent. 
2.  Balance. The standards development process should be balanced. Specifically, there 
should be meaningful involvement from a broad range of parties, with no single interest 
dominating the decision-making. 
3.  Due Process. Due process shall include documented and publicly available policies and 
procedures, adequate notice of meetings and standards development, sufficient time to 
review drafts and prepare views and objections, access to views and objections of other 
participants, and a fair and impartial process for resolving conflicting views. 
4.  Appeals Process. An appeals process shall be available for the impartial handling of 
procedural appeals. 
5.  Consensus. Consensus is defined as general agreement, but not necessarily unanimity. 
During the development of consensus, comments and objections are considered using 
fair, impartial, open, and transparent processes. 
These elements apply to activities related to the development of voluntary consensus standards 
nationally or internationally. For example, the International Electrotechnical Commission (IEC), 
International Organization for Standardization (ISO), Institute of Electrical and Electronics 
Engineers (IEEE) and ASTM International, usually develop standards that meet these criteria, as 
do standards developed in adherence with the American National Standards Institute (ANSI) 
Essential Requirements.4 FDA may also recognize standards developed in the private sector, for 
example, by professional societies, industry associations and other organizations such as The 
United States Pharmacopeia Convention (USP), that meet the criteria discussed in OMB Circular 
A-119. 
FDA prioritizes international and U.S. voluntary consensus standards for recognition; however, 
FDA may consider national standards of other countries when no international or U.S. national 
equivalent standard is available. Note that, in other cases, an international standard that another 
country or region adopts may be identical to standards recognized by FDA, e.g., ISO or IEC 
standards adopted as European Standards (EN/ISO), German standards (DIN/EN/ISO, 
DIN/ISO5), or British standards (BS/ISO); however, we will not ordinarily recognize the 
identical international standard separately. These standards may be used as described in the FDA 
guidance document, Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices.6 A sponsor should discuss with FDA its plans to use a 
national standard of another country, along with any other standards issues. 
FDA does not ordinarily consider normative references, i.e., standards referenced within an 
FDA-recognized consensus standard, for separate recognition. This is because normative 
references do not typically refer to an entire standard; rather, normative references typically refer 
to a specific clause or clauses. The citation of the normative reference within the FDA-
                                                
4 https://www.ansi.org/essentialrequirements 
5 Deutsches Institut fur Normung e.V. (German Institute for Standardization) 
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices 
3 Contains Nonbinding Recommendations 
recognized consensus standard will provide information about the extent to which the normative 
reference applies. 
In limited circumstances, FDA-recognized consensus standards are referenced within other 
standards recognized by FDA.  In these circumstances, manufacturers and others might wish to 
refer to more recent versions of the normative reference that have been recognized by FDA.  
More recent versions of the normative reference may address emerging issues of safety or 
technology before the currently-recognized standard is updated to incorporate more-recent 
normative references. 
For example, the 60601 family of standards includes multiple collaterals7 describing general 
testing for basic safety and essential performance and many particulars8 describing specific test 
methods by product type and application. A particular typically includes reference to a collateral, 
and a collateral is typically updated prior to the particulars that reference it. In the circumstance 
in which a manufacturer is using a particular that references a collateral and both standards are 
recognized by FDA, a manufacturer may wish to refer to the most recent version of the collateral 
that has been recognized by FDA. 
You will likely need knowledge of the normative references or referenced documents to 
appropriately apply that standard.   
A.   Recognition 
FDA recognizes standards by publication of a recognition list in the Federal Register. FDA 
will publish the recognition list at least annually. 
A list of consensus standards that FDA has recognized or decided to recognize is available on the 
FDA Recognized Consensus Standards Database Web site.9 Such standards are those that FDA 
has recognized by notice published in the Federal Register or that FDA has decided to recognize 
but for which recognition is pending (because a periodic notice has not yet appeared in the 
Federal Register).  The database will provide the most up-to-date list of suitable standards 
because, after FDA has decided to recognize a standard, we will update our online database to 
reflect the decision even before recognition of the standard.  The database will include a 
                                                
7 An IEC collateral standard is defined as a standard that addresses additional basic safety and essential performance 
requirements that are common to a subgroup of medical electrical equipment; or a standard that addresses additional 
basic safety and essential performance requirements that deal with characteristics of medical electrical equipment or 
medical electrical systems that are not fully covered by the general standard. See ANSI/AAMI ES60601-1:2005/(R) 
2012 and A1 2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text): Medical electrical equipment
Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). 
8 An IEC particular standard is defined as a standard that addresses additional basic safety and essential performance 
requirements that deal with characteristics of particular medical electrical equipment that are not covered by the 
general standard. 
9 FDA Recognized Consensus Standards Database for Medical Devices: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm 
4 Contains Nonbinding Recommendations 
recognition number and a Supplementary Information Sheet (SIS) for each decision, including 
for cases for which recognition is pending.10
B.   Requesting Recognition 
Any interested party may request recognition of a standard. A request for recognition of a 
standard should, at a minimum, contain the following information:  
  name and electronic or mailing address of the requestor 
  title of the standard  
  any reference number and date  
  proposed list of product types for which a Declaration of Conformity (DOC) should 
routinely apply  
  basis for recognition, e.g., including the scientific, technical, regulatory, or other basis for 
the request 
  a brief identification of the testing or performance or other characteristics of the product(s) 
or process(es), that would be addressed by a DOC.  
Additional advice on procedures for requesting standards for recognition may be found at 
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-
program/recognition-standard. Requests may be submitted by mail in writing to the Standards 
and Conformity Assessment Program (S-CAP) at the address below or electronically through 
CDRHStandardsStaff@fda.hhs.gov. 
Standards and Conformity Assessment Program 
Office of Strategic Partnerships and Technology Innovation 
Center for Devices and Radiological Health 
10903 New Hampshire Avenue 
WO66 
Silver Spring, MD 20993-0002 
In general, FDA will not automatically request copies of the standard submitted for recognition. 
However, there may be certain standards to which the Agency does not have access, such as 
country specific standards. Therefore, we recommend contacting S-CAP at 
CDRHStandardsStaff@fda.hhs.gov prior to submitting a standards recognition request to 
determine whether the Agency has access to the standard.  
When the Agency receives a request for recognition of a standard, we intend to mail or email an 
Acknowledgment Letter to the contact person identified in the request. The Acknowledgment 
                                                
10 A sponsor may rely on an unrecognized standard. For more information, see the FDA guidance 
document, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-
use-voluntary-consensus-standards-premarket-submissions-medical-devices 
5 Contains Nonbinding Recommendations 
Letter will identify the date of receipt (this is the date that FDA received the request), the title of 
the standard, and a contact person at FDA who is assigned to oversee the recognition request. 
C.   Extent of Recognition: Complete or Partial Recognition 
FDA may recognize or decide to recognize all or part of a standard.11 The extent of recognition 
(EOR) is FDAs determination regarding which parts of a standard are appropriate for 
recognition. Within this context, recognize is a specific term derived from section 514(c) of the 
FD&C Act, referring to the process for FDA identification of standards, which demonstrate 
scientific and technical merit, that manufacturers of medical products may cite to meet relevant 
requirements of the FD&C Act and implementing regulations. The EOR section of the SIS 
specifies the extent to which a standard is recognized. See section V for more information about 
the supplementary information. 
S-CAP is responsible for reviewing and recommending the supplementary information that 
accompanies each standard that is recognized. S-CAP staff may contact the submitter for 
additional clarification regarding the request for recognition.  
Complete Recognition 
For a standard that can be recognized in its entirety the EOR will state Complete Standard 
followed by the basis for that determination.  FDA may have more than one reason for its 
determination.12
Partial Recognition 
For a standard that can be recognized in part, the EOR will state Partial Recognition followed 
with text that lists the part(s) of the standard that is/are not recognized. The titles and numbers of 
non-recognized sections or clauses of the standard will be listed sequentially as they appear in 
the standard stating that they are not recognized. FDA will provide its rationale (basis for that 
determination) for the part(s) of the standard that are and are not recognized.  
D.   Non-Recognition 
Non-recognition of a standard, while it does not preclude the appropriate use of a standard under 
general use,13 means that the standard generally does not satisfy or would not be helpful in 
satisfying a portion of the statute or regulations. FDAs rationale for this decision will be 
communicated to the submitter of the request and the decision will be listed on the Non-
                                                
11 See the FDA guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices. 
12  The Supplementary Information Sheet (SIS) (discussed in Section V. of this guidance) includes a section titled 
Rationale for Recognition, which is considered the basis for such determination discussed 514(c)(1)(C)(ii)(II).  
13 See the FDA guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices. 
6 Contains Nonbinding Recommendations 
Recognized Standards database.14 FDA will explain the technical, scientific, regulatory, or other 
basis for the decision.15 If the standard contains specifications or methods that are not 
scientifically acceptable, not technically feasible, or conflict with existing FDA-recognized 
consensus standards, existing published policies, regulation, or the statute, FDA generally would 
not recognize the standard. FDA may also decide not to recognize a standard that creates a 
barrier to domestic or international trade or that impedes innovation or technical progress. If 
FDA decides not to recognize a standard, it would not receive a recognition number. 
E.   Notification of Determination 
The statute directs FDA to make a determination on recognition (complete or partial) or non-
recognition no later than 60 calendar days from the date the request was received. When such a 
determination is made, the Agency will issue the determination letter to the submitter by mail 
using the mailing address provided or electronically using the email address provided. We will 
officially recognize the standard (completely or partially) by subsequent publication in the 
Federal Register. Note that the determination (and corresponding update to our database) may 
precede recognition via publication of the standard in the Federal Register through updates to the 
FDA Recognized Consensus Standards Database for Medical Devices.16
V. Supplementary Information 
The recognition of a standard typically includes a SIS for each standard recognized. This 
document, developed by FDA is intended to assist manufacturers and product developers should 
they elect to use standards in their development, manufacturing, or for other purposes. The SIS 
includes the standards scope and other helpful information. The SIS for most vertical standards, 
e.g., product-specific standards, includes a list of relevant regulations and product codes for 
which the standard may be applicable. Although the Agency makes every effort to keep the list 
in the SIS current, note that new product codes are continually being created, and as such the list 
may not always be up to date. The list of product codes is intended to provide examples of 
products for which the standard may be applicable and is not intended to be exhaustive. Product 
codes and regulations are typically not provided for horizontal standards, e.g., biocompatibility 
or sterility standards, because maintaining a representative list would be impractical given the 
number of products impacted. 
A.   Essential Information Provided 
The SIS typically includes essential information such as the recognition number and FDA 
Specialty Task Group (STG). Other information may include the standards designation number, 
                                                
14 See Non-Recognized Standards database, 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/nr_results.cfm 
15 See section 514(c)(1)(C)(ii) and (D) of the FD&C Act. 
16 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm 
7 Contains Nonbinding Recommendations 
date of publication, title, scope, U.S. parallel adoption (if any),17 extent of recognition (complete 
or partial), rationale for recognition,18 date of recognition, and transition periods (if any).19  
B.   Scope 
FDA intends to include the standards scope in the SIS to assist manufacturers and FDA 
staff in determining whether the standard may be useful to them. Where a standards scope 
is extensive, the main body of the scope will be included with reference to the website 
where the entire scope can be located.   
C.   FDA Decision Making Rationale 
Recognition of a voluntary consensus standard, either in whole or in part, can help facilitate 
meeting a requirement under the FD&C Act or implementing regulations. For example, the 
standard may satisfy requirements regarding performance specifications, labeling, informed 
consent, or post market activity. A standard may be relevant for a specific device, group of like 
devices, or a broad range of devices and medical products. A standard may also satisfy 
requirements related to Quality Systems Regulations, risk management, or Good Laboratory 
Practices, as examples. 
FDA will provide its rationale for recognition of the standard in the SIS, including the scientific, 
technical, regulatory, or other basis, as applicable. For the regulatory basis, FDA intends to 
provide supporting information illustrating the standards regulatory applicability. For example, 
how the standard(s) is/are relevant to FDA regulatory processes, guidance and/or supportive 
publications. 
VI. Withdrawal of Recognition 
FDA may withdraw recognition of a previously recognized standard if the Agency determines 
that the standard is no longer appropriate to support a DOC for meeting a requirement regarding 
devices under the FD&C Act (see section 514(c)(2)). The two primary situations where FDA 
may make this determination are described below. 
A. FDA-Recognized Consensus Standard Replaced by New 
Version 
When an SDO issues a new version or revision that supersedes a standard recognized by FDA, 
FDA reviews the changes and decides whether to recognize the new version. If the new version
                                                
17 Identical or parallel U.S. adoption is when the United States, through ANSI, adopts (in parallel) a standard 
published by an international SDO, such as ISO or IEC, without modification to its content. FDA will update the 
SIS of the international standard on our website when either ANSI or a U.S. SDO publishes the parallel adoption. 
Since such standards are identical, we will not ordinarily assign a separate recognition number or separately 
announce recognition in the Federal Register. 
18 See section 514(c)(1)(C)(ii) of the FD&C Act. 
19 For further information regarding transition periods of recognized standards, please refer to the FDA guidance, 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.  
8 Contains Nonbinding Recommendations  
is recognized, we will announce the change, i.e., recognition of the new version and (usually) 
withdrawal of the older version, in a notice published in the Federal Register. We will add the 
new version to the Recognized Consensus Standards database, and we will remove the older 
version from the database.  
FDA may provide a transition period during which both the old and new versions of a standard 
are recognized. This means that, per 514(c)(1)(A), a DOC may be submitted for either FDA-
recognized consensus standard (i.e., the new or the older version). Once we withdraw recognition 
of the old version, a DOC to the old version of the standard will no longer be acceptable for 
future submissions. The transition period, if any, will be included in the SIS. Note that a 
transition period is only applicable to standards whose recognition is being withdrawn.   
When determining the timing of a transition period, FDA considers the public health impact of 
delaying implementation of significant scientific updates and the difficulty manufacturers may 
face while implementing the specific changes in the new version compared to the older version. 
For example, a standard with only minor technical or editorial changes may have a shorter 
transition period than a standard with changes that may take longer to implement.  When a 
change to the standard impacts an emergent public health issue, FDA may assign a shortened or 
no transition period to respond to the issue with appropriate timeliness. For additional discussion 
regarding transition periods, please see the FDA guidance document Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices.20    
Standards may be revised after marketing authorization is granted. As discussed in section VIII. 
of the FDA guidance document Appropriate Use of Voluntary Consensus Standards in 
Premarket Submissions for Medical Devices, changes in a recognized consensus standard do 
not retroactively affect a products clearance or approval status.  
B. FDA-Recognized Consensus Standard no longer 
appropriate for meeting a requirement 
FDA may withdraw recognition of a standard if it determines that the standard is no 
longer appropriate for meeting a requirement regarding devices (section 514(c)(2) of the 
FD&C Act).  In such an instance, a notice would be published in the Federal Register 
withdrawing FDA recognition.  Use of non-recognized standards are discussed in the FDA 
guidance document Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices. 
 
VII. Paperwork Reduction Act of 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).  
 
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices  
   9   Contains Nonbinding Recommendations  
 
The time required to complete this information collection is estimated to be 1 hour per request. 
Send comments regarding this burden estimate or suggestions for reducing this burden to:  
 
FDA PRA Staff,  
Office of Operations,  
Food and Drug Administration,  
PRAStaff@fda.hhs.gov  
 
An agency may not conduct or sponsor, and a person is not required to respond 
to, a collection of information unless it displays a currently valid OMB control 
number. The OMB control number for this information collection is 0910-
0120 (To find the current expiration date, search for this OMB control number 
available at https://www.reginfo.gov). 
 
   10