[Federal Register Volume 64, Number 93 (Friday, May 14, 1999)]
[Proposed Rules]
[Pages 26330-26344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12040]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 607, and 807

[Docket No. 98N-1215]


Foreign Establishment Registration and Listing

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations pertaining to the registration of foreign 
establishments and the listing of human drugs, animal drugs, biological 
products, and devices. The proposal would require foreign 
establishments whose products are imported or offered for import into 
the United States to register with FDA. The proposal would also require 
foreign establishments to identify a United States agent and would 
describe some of the agent's responsibilities. The agency is proposing 
these changes to implement section 417 of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) as it pertains to 
foreign establishment registration.

DATES: Written comments by July 28, 1999. Written comments on the 
information collection requirements by June 14, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit written comments on the information 
collection requirements to the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB), New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20502, Attn: Wendy 
Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    On November 21, 1997, the President signed FDAMA into law (Pub. L. 
105-115). Section 417 of FDAMA amended section 510(i) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(i)) to require, 
in part, that:
    (1) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing of 
a drug or a device that is imported or offered for import into the 
United States shall register with the Secretary the name and place 
of business of the establishment and the name of the United States 
agent for the establishment.
    (2) The establishment shall also provide the information 
required by subsection (j).
     * * *
(Section 510(j) of the act pertains to product listing.)
    Generally speaking, before FDAMA's enactment, foreign 
establishments could, but were not required to, register with FDA. 
Foreign establishments were required, however, to list their products 
regardless of whether the foreign establishment was registered (see, 
e.g.,

[[Page 26331]]

former section 510(i) of the act, Sec. 207.40(a) (21 CFR 207.40(a)) (38 
FR 6258 at 6267, March 7, 1973)). This generated confusion and resulted 
in foreign establishments not complying with the listing requirement. 
Moreover, in some cases, the lack of registration information on 
foreign establishments made it difficult to determine the source of 
specific imported products, particularly products that were impure, 
counterfeit products, or products whose safety or efficacy had not been 
established.
    In contrast, before FDAMA was enacted, the act required--and 
continues to require--all domestic establishments to register unless 
they are specifically exempted from the registration requirement and to 
list their products.
    FDAMA changed this situation by requiring all foreign 
establishments engaged in the manufacture, preparation, propagation, 
compounding, or processing of a drug or a device that is imported or 
offered for import into the United States to register. It also 
emphasized that foreign establishments must list their products. Thus, 
under the act, as revised by FDAMA, both foreign and domestic 
establishments must now register and list their products.

II. Description of the Proposed Rule

    The proposed rule would amend the establishment registration and 
listing regulations in part 207 (21 CFR part 207) (human and animal 
drugs), part 607 (21 CFR part 607) (human blood and blood products), 
and part 807 (21 CFR part 807) (devices). In general, the proposal 
would remove the distinctions between domestic and foreign 
establishments where appropriate, would require foreign establishments 
to identify a United States agent, and would describe some of the 
United States agent's duties.
    The proposal would also make minor technical amendments, such as 
updating addresses of FDA offices and the names of marketing 
applications, to be consistent with current FDA practices.
    The proposed rule would not affect veterinary biologics because 
such products are regulated by the U.S. Department of Agriculture.

A. Proposed Changes to Part 207 (Human Drugs and Animal Drugs)

1. Section 207.3--Definitions
    a.  Definition of ``commercial distribution''. Section 207.3(a)(5) 
currently defines ``commercial distribution'' as:
    any distribution of a human drug except for investigational use 
under part 312 of this chapter, and any distribution of an animal 
drug or an animal feed bearing or containing an animal drug for 
noninvestigational uses, but the term does not include internal or 
interplant transfer of a bulk drug substance between registered 
domestic establishments within the same parent, subsidiary, and/or 
affiliate company.
    The proposed rule would add a new sentence to this definition to 
clarify that, for foreign establishments, commercial distribution does 
not include distribution of a human or animal drug that is neither 
imported nor offered for import into the United States. This change is 
intended to reflect the statutory language limiting the registration 
requirement to those foreign establishments that are ``engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug or a device that is imported or offered for import into the United 
States'' (emphasis added), as well as the definition of ``interstate 
commerce'' in section 201(b) of the act (21 U.S.C. 321(b)).
    b. Definition of ``United States agent''. The proposed rule would 
define ``United States agent,'' at new Sec. 207.3(a)(11), as ``a person 
residing or maintaining a place of business in the United States whom a 
foreign establishment designates as its agent.'' Black's Law Dictionary 
defines ``reside'' as ``live, dwell, abide, sojourn, stay, remain, 
lodge'' and ``to settle oneself or a thing in a place, to be stationed, 
to remain or stay, to dwell permanently or continuously * * *'' (see 
Black's Law Dictionary 1308 (6th ed. 1990)) and defines ``place of 
business,'' in part, as ``The location at which one carries on his 
business or employment'' (id. at 1149). Thus, by using the term 
``residing'' and referring to a ``place of business,'' proposed 
Sec. 207.3(a)(11) would permit a foreign establishment to designate, as 
its United States agent, either an individual who lives in the United 
States or a firm or company in the United States where an individual or 
individuals conduct business or are employed. The definition of United 
States agent would exclude mailboxes, answering machines or services, 
or other places where an individual acting as the foreign 
establishment's agent is not physically present.
    Additionally, FDA emphasizes that it interprets section 510(i)(1) 
of the act as allowing for only one United States agent for each 
foreign establishment, for purposes of section 510(i) of the act. This 
interpretation is both efficient (because FDA would communicate or 
interact with only one United States agent rather than multiple agents 
who represent or purport to represent the same foreign establishment) 
and consistent with section 510(i)(1) of the act because the act refers 
to the United States agent in singular, rather than plural, terms.
2. Section 207.7--Establishment Registration and Product Listing for 
Human Blood and Blood Products and for Medical Devices
    Section 207.7(a) currently states, in part, that owners and 
operators of human blood and blood product establishments are to 
register and list their products in accordance with part 607.
    The proposal would revise the address for the office in the Center 
for Biologics Evaluation and Research that receives the registration 
and listing information.
3. Section 207.10--Exemptions for Domestic Establishments
    Currently, Sec. 207.10 exempts various domestic entities or persons 
from the registration requirements. Some exemptions reflect the 
statutory language in section 510(g) of the act, whereas others were 
exempted by FDA because registering such persons would not be necessary 
to protect the public health.
    The proposed rule would amend Sec. 207.10 to delete the word 
``domestic'' from its title, so that the provision pertains to 
exemptions for both foreign and domestic establishments. FDA is 
proposing this change because the establishment registration 
requirements now apply to both domestic and foreign establishments, so 
no further distinction is necessary in the heading of Sec. 207.10.
    However, the exemptions currently found in Sec. 207.10(a) and (b) 
(pertaining to pharmacies operating under applicable local laws and to 
hospitals, clinics, and public health agencies that maintain 
establishments in conformance with local laws regulating the practice 
of pharmacy or medicine) would remain limited to establishments in the 
United States and its territories. FDA is not proposing to extend these 
exemptions to foreign pharmacies, hospitals, clinics, and public health 
agencies because the statutory exemption for pharmacies in section 
510(g)(1) of the act does not extend to foreign pharmacies and because 
FDA has limited experience with or access to foreign laws on the 
practice of pharmacy or medicine and, therefore, cannot readily 
determine whether these foreign establishments are in compliance with 
such laws. The agency also lacks sufficient information to make a 
finding, under section 510(g)(5) of the act, that registration by such 
foreign establishments is not

[[Page 26332]]

necessary to protect the public health. However, it is unlikely that 
many foreign pharmacies, hospitals, clinics, or public health agencies 
export or offer to export drugs or devices to the United States, so few 
of these foreign establishments should be subject to the registration 
requirement. Those that do export to the United States should be in 
FDA's inventory of registered foreign establishments for the efficient 
administration and enforcement of the act.
4. Section 207.20--Who Must Register and Submit a Drug List
    Section 207.20(a) currently requires ``owners and operators of all 
drug establishments, not exempt under section 510(g) of the act or 
subpart D of this part 207, that engage in the manufacture, 
preparation, propagation, compounding, or processing of a drug or 
drugs'' to register and list every drug in commercial distribution. The 
rule also states that owners and operators must register and list every 
drug in commercial distribution ``whether or not the output of such 
establishment or any particular drug so listed enters interstate 
commerce * * *.'' However, under the current rule, drug listing is not 
required ``at this time for the manufacturing, preparation, 
propagation, compounding, or processing of an animal feed (including a 
Type B and Type C medicated feed) bearing or containing an animal drug 
* * *.''
    The proposed rule would amend Sec. 207.20(a) to clarify that the 
exemptions are under section 510(g) of the act or subpart B 
(``Exemptions'') of part 207. The agency is making this change because 
the proposed rule would place all exemptions in subpart B of part 207 
and would remove all exemptions from subpart D.
    The proposal would also revise Sec. 207.20(a) so that the language 
requiring owners and operators to register their establishments and to 
list drugs, whether or not the output of the establishment or any 
particular drug so listed enters interstate commerce, would apply only 
to domestic firms. FDA is proposing this change because the agency has 
no intent to require foreign establishments to list drugs that do not 
enter interstate commerce by being imported or offered for import into 
the United States.
    The proposal would also make two minor amendments to 
Sec. 207.20(a). The proposed rule would delete the phrase ``at this 
time'' because the phrase is unnecessary. The proposal would also move 
the parenthetical language referring to Type B and Type C medicated 
feed so that it refers accurately to animal feeds bearing or containing 
an animal drug rather than to animal feeds generally and revise the 
parenthetical language so that it refers to Type B ``or'' Type C 
medicated feed. This would eliminate any misconception that the product 
be both a Type B and Type C medicated feed.
    Additionally, FDA notes that Sec. 207.20(a), as currently written, 
permits a company to submit listing information on behalf of a parent, 
subsidiary, and/or affiliate company for all establishments when 
operations are conducted at more than one establishment and there 
exists joint ownership and control among all the establishments. FDA 
interprets this provision, and similar provisions at Secs. 607.20(a) 
and 807.20(a), as including foreign establishments so long as 
operations are conducted at more than one establishment and there 
exists joint ownership and control among all the establishments.
    The proposed rule would also add ``abbreviated new drug 
applications'' and ``abbreviated new animal drug applications'' to the 
list of marketing applications in Sec. 207.20(c). FDA is proposing 
these actions because such applications, which were created by the Drug 
Price Competition and Patent Term Restoration Act and the Generic 
Animal Drug and Patent Term Restoration Act, are marketing applications 
that require a registered establishment. These applications were 
inadvertently omitted from previous rulemakings amending part 207. (The 
agency notes that, in the Federal Register of July 31, 1998 (63 FR 
40858), it published a proposed rule that would eliminate establishment 
and product licenses and implement biologics licenses.)
5. Section 207.21--Times for Registration and Drug Listing
    Section 207.21 currently describes when establishments should 
register and submit listing information and states that an owner or 
operator of an establishment that has just begun manufacturing or 
processing drugs should register within 5 days after submitting a new 
drug application, new animal drug application, medicated feed 
application, antibiotic application, or an establishment license 
application to manufacture a biological product. (The agency notes 
that, in the Federal Register of July 31, 1998 (63 FR 40858), it 
published a proposed rule that would eliminate establishment and 
product licenses and implement biologics licenses.)
    The proposed rule would add ``abbreviated new drug applications'' 
and ``abbreviated new animal drug applications'' to the list of 
marketing applications in Sec. 207.21. As stated earlier, these 
applications were inadvertently omitted from previous rulemakings 
amending part 207.
6. Section 207.25--Information Required in Registration and Drug 
Listing
    Section 207.25(b)(2) currently requires the numbers for various 
marketing applications to be included in the drug listing information 
submitted to the agency. For example, if a new drug application were 
assigned number 20-570, the application number that would be included 
in the drug listing information would be NDA 20-570.
    The proposed rule would add abbreviated new animal drug 
applications to the list of marketing applications in Sec. 207.25. As 
stated earlier, this action is necessary because abbreviated new animal 
drug applications were inadvertently omitted from previous rulemakings 
amending part 207.
7. Section 207.37--Inspection of Registrations and Drug Listings
    Section 207.37(a) currently states where copies of registration 
forms filed by establishments are available for inspection. In general, 
the forms are available at the Center for Drug Evaluation and Research 
and at FDA district offices.
    The proposed rule would amend Sec. 207.37(a) to update the 
addresses in the Center for Drug Evaluation and Research and would 
state that copies of registration forms submitted by foreign 
establishments are available for inspection at the Office of Compliance 
in the Center for Drug Evaluation and Research. Copies of forms 
submitted by domestic establishments would continue to be available for 
inspection at FDA district offices and at the Office of Compliance in 
the Center for Drug Evaluation and Research.
    The proposal would also update the addresses in Sec. 207.37(b).
8. Section 207.40--Drug Listing Requirements for Foreign Drug 
Establishments
    Section 207.40 currently requires foreign drug establishments to 
comply with drug listing requirements and prohibits the importation of 
drugs that are not listed (except for investigational drugs). It also 
requires foreign establishments to submit drug listing information in 
English and to provide the name and address of the

[[Page 26333]]

establishment and the person responsible for submitting the drug 
listing information.
    Proposed Sec. 207.40(a) would revise the existing language to 
require foreign establishments whose drugs are imported or offered for 
import into the United States to comply with the establishment 
registration and listing requirements in subpart C (``Procedures for 
domestic drug establishments''), unless exempt under subpart B 
(``Exemptions''). The proposal would expressly require foreign 
establishments to register as required by section 510(i)(1) of the act.
    Proposed Sec. 207.40(b) would prohibit the importation of drugs 
from unregistered foreign establishments, in addition to prohibiting 
the importation of unlisted drugs. This action is consistent with 
several provisions of the act. Section 301(p) of the act (21 U.S.C. 
331(p)) considers a foreign establishment's failure to register or to 
submit listing information to be a prohibited act. Section 501(a)(2)(B) 
of the act (21 U.S.C. 351(a)(2)(B)) considers a drug to be adulterated 
if the methods used in or the facilities or controls used for the 
drug's manufacture, processing, packing, or holding do not conform to 
current good manufacturing practice (CGMP). Additionally, under section 
801(a) of the act (21 U.S.C. 381(a)), FDA may refuse to admit into the 
United States drugs that appear to be: (1) Manufactured, processed, or 
packed under insanitary conditions; (2) forbidden or restricted in sale 
in the country in which they are produced or from which they are 
exported; or (3) adulterated, misbranded, or in violation of section 
505 of the act (21 U.S.C. 355). Here, if a foreign establishment fails 
to register (thereby engaging in a prohibited act), it is likely that 
FDA has not inspected the establishment. As a result, FDA would be 
unable to determine whether that foreign establishment meets CGMP. 
Consequently, drugs from such unregistered establishments would appear 
to be adulterated under section 801(a)(3) of the act. Therefore, to 
enforce sections 301(p), 501(a), and 801(a) of the act effectively, in 
conjunction with section 510(i) of the act as it pertains to foreign 
establishment registration, the agency is proposing to amend 
Sec. 207.40(b) to prohibit the importation of drugs that are not 
manufactured, prepared, propagated, compounded, or processed at a 
registered foreign establishment.
    Moreover, this interpretation is consistent with the purpose of the 
registration provision as originally enacted in 1962. While the FDAMA 
legislative history is virtually silent on the purpose of foreign 
registration, the Drug Amendments of 1962 make clear the connection 
between registration and factory inspection. The Drug Amendments 
amended the act to include, among other things, a registration 
provision requiring domestic drug establishments to register and 
authorizing foreign establishments to register, and a ``current good 
manufacturing practice'' provision which now appears at section 
501(a)(2)(B) of the act. According to the Senate Report accompanying 
the amendments, the purpose of the registration provision is
    to assist the [FDA] to identify and inspect all places where 
drugs are being made, and to take appropriate action * * * against 
those who fail to register * * * The committee believes that drugs 
should not be on the market unless the [FDA] knows who is making 
them, and where they are being made, and is able to inspect the 
facilities in which they are being made. This will help to stop 
illicit and substandard manufacturers who do not follow the methods 
or establish the controls called for by good manufacturing practice. 
The registration system * * * is thus a facet of * * * the 
provisions on quality manufacturing controls * * *.''
S. Rept. 87-1744 (1962), reprinted in 1962 U.S.C.C.A.N., 2884, 2888-89. 
Therefore, the agency believes that the act supports a prohibition on 
importation of drugs manufactured by unregistered establishments.
    FDA acknowledges that section 502(o) of the act (21 U.S.C. 352(o)) 
considers a drug to be misbranded if the drug was manufactured, 
prepared, propagated, compounded, or processed in an establishment that 
is not registered in any State and that FDAMA did not amend section 
502(o) of the act to include language describing a similar restriction 
on drugs from unregistered foreign establishments. Nevertheless, as 
explained above, FDA has sufficient legal authority to prohibit the 
importation of drugs from unregistered foreign establishments, as a 
regulation for the efficient enforcement of the act under section 
701(a) of the act (21 U.S.C. 371(a)), and such a prohibition would give 
foreign establishments, like their domestic counterparts, an incentive 
to register.
    Proposed Sec. 207.40(b) would also require foreign establishments 
to submit registration and listing information, including labels and 
labeling, in English. This would be consistent with the existing 
provision which requires that listing information be submitted in the 
English language.
    Section 207.40(c) currently requires every foreign drug 
establishment to submit, as part of its drug listing, the 
establishment's name and address and the name of the individual 
responsible for submitting the listing information. It also directs the 
foreign establishment to report any changes at specified intervals.
    The proposed rule would revise Sec. 207.40(c) to require each 
foreign establishment to submit the name, address, and phone number of 
its United States agent as part of the establishment's initial and 
updated registration information. As stated earlier, FDA interprets 
section 510(i) of the act as allowing for only one United States agent 
for each foreign establishment and providing a foreign establishment 
the discretion to choose either an individual person or entity to serve 
as its United States agent. Some establishments may prefer to select a 
company or firm as the United States agent rather than depend on a 
single person, and so proposed Sec. 207.40(c) would allow an entity to 
be the United States agent.
    Proposed Sec. 207.40(c) would also require a foreign establishment 
to report changes in the United States agent's name, address, or phone 
number to FDA within 5 days of the change and would require each 
foreign establishment to designate only one United States agent. In 
drafting this provision, FDA considered allowing such changes to be 
reported either by the foreign establishment or by the United States 
agent because, on rare occasions, the agency has contacted individuals 
whom establishments had identified as their agent or representative 
only to find that the individual had terminated its relationship with 
the establishment or was unaware that the establishment had designated 
the individual as its representative. Although the proposal would 
permit only establishments to report changes in the United States 
agent's name, address, or phone number, the agency invites comments as 
to whether the rule should permit the United States agent to report 
such changes as well.
    Additionally, proposed Sec. 207.40(c) would require the United 
States agent to reside or maintain a place of business in the United 
States, and, upon request from FDA, to assist FDA in communications 
with the foreign drug establishment, to respond to questions about the 
establishment's products that are imported or offered for import into 
the United States, and to assist FDA in scheduling inspections of the 
foreign drug establishment. For example, in the event of a product 
recall, the agency might ask the United States agent about the 
product's distribution in the United

[[Page 26334]]

States in order to facilitate the recall (although, in many instances, 
FDA will either have information on the imported product's distribution 
or be able to acquire such information from other government agencies 
so as to reduce the need to contact the United States agent on such 
matters). The agency is proposing these requirements because its 
experience indicates that communications with foreign establishments 
are much better and problems or concerns are resolved much faster when 
the agency can work with a person residing or maintaining a place of 
business in the United States.
    FDA considered, but did not propose, a requirement that the United 
States agent possess sufficient knowledge of English to facilitate 
communications between FDA and the foreign establishment. The agency 
chose to omit such a requirement, in part, because the United States 
agent, by virtue of residing or maintaining a place of business in the 
United States, should be able to communicate in English or may be 
assumed to have sufficient knowledge of English. Should this assumption 
prove to be incorrect, FDA may revise the rule to require the United 
States agent to be able to communicate in English.
    The proposal would also consider information or documents provided 
by FDA to the United States agent to be equivalent to providing the 
same information or documents to the foreign drug establishment. This 
provision would apply when the agency is unable to contact the foreign 
manufacturer directly or expeditiously, including (but not limited to) 
situations where FDA has been unsuccessful in contacting the foreign 
establishment directly because the establishment has moved, when FDA 
correspondence sent directly to the foreign establishment has been 
returned to the agency because the local postal authorities cannot 
locate the foreign establishment, or in emergencies. This proposed 
provision, however, suggests that foreign establishments should select 
their United States agent carefully. FDA is aware that some foreign 
establishments have multiple distributors in the United States, but 
sometimes select one distributor as the establishment's representative 
or agent. This may present a problem if FDA, under proposed 
Sec. 207.40(c), sought to provide certain documents or information to a 
distributor-agent concerning products that might have been supplied to 
or actions taken by a different distributor. For example, foreign 
establishment ``A'' might have three distributors in the United States 
(distributors ``B,'' ``C,'' and ``D'') and have selected distributor B 
as its United States agent. If FDA, under proposed Sec. 207.40(c), were 
to contact distributor B, in its capacity as the United States agent, 
about problems associated with a particular import, such contact might 
inadvertently present business concerns for the foreign establishment 
because distributor B might be unaware of other distributors in the 
United States or other products shipped to the United States, or FDA 
might be unaware that the information concerned a product that had not 
been shipped to distributor B. Distributor B also might not relay the 
information from FDA to the foreign establishment if the failure to 
relay the information would confer a competitive advantage to itself.
    Contact between FDA and a United States agent might also present 
issues involving trade secrets or confidential commercial information. 
For example, section 301(j) of the act, with few exceptions, prohibits 
the agency from disclosing trade secrets. Yet there may be instances 
where the agency needs to discuss information which may involve trade 
secrets or confidential commercial information. If the agency is unable 
to contact the foreign manufacturer, it may not be permitted to discuss 
the information with the United States agent, even if a public health 
emergency exists.
    Thus, FDA advises foreign establishments to choose their United 
States agents carefully in order to avoid any conflict of interest or 
confidentiality problems.

B. Proposed Changes to Part 607 (Human Blood and Blood Products)

1. Section 607.3--Definitions
    a. Definition of ``commercial distribution''. Section 607.3(e) 
currently defines ``commercial distribution,'' in part, as ``any 
distribution of a blood product except pursuant to the investigational 
use provisions of part 312 of this chapter * * *.''
    The proposal would add a new sentence to Sec. 607.3(e) to state 
that, for foreign establishments, commercial distribution does not 
include distribution of any blood or blood product that is neither 
imported nor offered for import into the United States. This change is 
necessary because FDA does not intend to require foreign establishments 
to register or to list blood products that are not imported to or 
offered for import into the United States, consistent with the language 
of section 510(i)(1) of the act.
    b. Definition of ``United States agent''. The proposed rule would 
define ``United States agent,'' in a new Sec. 607.3(j), as ``any person 
residing or maintaining a place of business in the United States whom a 
foreign establishment designates as its agent.'' This definition, and 
FDA's interpretation of the definition, would be identical to those in 
proposed Sec. 207.3(a)(11).
2. Section 607.7--Establishment Registration and Product Listing of 
Blood Banks and Other Firms Manufacturing Human Blood and Blood 
Products
    Section 607.7(b) and (c) currently provide an address for the 
Center for Biologics Evaluation and Research from which registration 
forms may be obtained and to which they may be sent.
    The proposed rule would amend Sec. 607.7(b) and (c) to update the 
address.
3. Section 607.20--Who Must Register and Submit a Blood Product List
    Section 607.20(a) currently states, in part, that an owner or 
operator of an establishment that engages in the manufacture of blood 
products must register and submit a list of every blood product in 
commercial distribution, ``whether or not the output of such blood 
product establishment or any particular blood product so listed enters 
interstate commerce.''
    The proposal would revise Sec. 607.20(a) so that the language 
requiring owners and operators to register their establishments and to 
list blood products whether or not the output of the establishment or 
any particular blood product so listed enters interstate commerce 
applies only to domestic firms. This change is consistent with proposed 
Sec. 607.3(e).
4. Section 607.22--How and Where to Register Establishments and List 
Blood Products
    Section 607.22 currently describes which forms should be used for 
registration and listing purposes and provides an address from which 
the forms may be obtained. Section 607.22(b) further states that 
listing information may be submitted on computer tapes.
    The proposed rule would update FDA's addresses in Sec. 607.22(a). 
The proposal would also amend Sec. 607.22(b) to delete the language 
concerning tapes for computer input and the submission of proposed 
formats for FDA review and approval. FDA is proposing to delete this 
provision because it has never been used.

[[Page 26335]]

5. Section 607.25--Information Required for Establishment Registration 
and Blood Product Listing
    Section 607.25(a), in describing FDA Form FD-2830, uses the words 
``post office ZIP code.''
    The proposal would revise Sec. 607.25(a) to refer to a post office 
code. This change reflects the fact that many foreign countries do not 
use the term ``ZIP'' code.
6. Section 607.26--Amendments to Establishment Registration
    Section 607.26 requires changes in individual ownership, 
``corporate or partnership structure location or blood-product handling 
activity'' to be reported. This provision was intended to require, 
among other things, firms to report changes in corporate or partnership 
structure as well as changes in location, but was occasionally 
misinterpreted as applying solely to changes in location.
    Consequently, the proposal would revise this language to read as 
``Changes in individual ownership, corporate or partnership structure, 
location, or blood-product handling activity'' to clarify that changes 
in corporate or partnership structure or location or blood-product 
handling activity are to be reported.
7. Section 607.31--Additional Blood Product Listing Information
    Section 607.31 describes additional information that FDA may 
require by letter, but states that the Commissioner will perform 
various actions, such as making a request or a finding, before 
requiring the additional information.
    The proposal would substitute the ``Director of the Center for 
Biologics Evaluation and Research'' for the ``Commissioner'' throughout 
Sec. 607.31(a) because the center director, rather than the 
Commissioner, performs those functions.
    The proposal would also delete the text in Sec. 607.31(b) 
pertaining to the voluntary reporting of information on the quantity of 
blood product distributed. FDA is proposing to delete the text in 
paragraph (b) because the form specified in the rule, Form FD-2831 
(Blood Establishment Resource Summary), is obsolete, and the provision 
has not been used.
8. Section 607.35--Notification of Registrant; Blood Product 
Establishment Registration Number and NDC Labeler Code
    Section 607.35(a) currently states that the Commissioner will 
provide a validated copy of form FD-2830 to the location shown for the 
registering establishment.
    The proposal would amend Sec. 607.35(a) to state that a copy will 
also be sent to the reporting official if that official is at another 
address. This would accommodate those employees or representatives who 
submit registration and listing information for an establishment but 
are not located at that establishment.
    The proposal would also substitute the ``Director of the Center for 
Biologics Evaluation and Research'' for the ``Commissioner'' because 
the center director, rather than the Commissioner, performs that 
function.
9. Section 607.37--Inspection of Establishment Registrations and Blood 
Product Listings
    Section 607.37 currently lists addresses where filed forms are 
available for inspection or where requests for information regarding 
blood establishment registration and listing should be sent.
    The proposal would update the addresses.
10. Section 607.40--Establishment Registration and Blood Product 
Listing Requirements for Foreign Blood Product Establishments
    Currently, Sec. 607.40, entitled ``Blood product listing 
requirements for foreign blood product establishments,'' requires such 
establishments to comply with blood product listing requirements and 
prohibits the importation of most nonlisted blood products. The 
provision also requires foreign blood product establishments to submit 
listing information in English and, as part of their listing, to submit 
the name and address of the establishment and the name of the 
individual responsible for submitting the product listing information.
    Proposed Sec. 607.40(a) would require foreign establishments to 
comply with establishment registration requirements in addition to 
blood product listing requirements. To complement this change, the 
proposal would revise the title to Sec. 607.40 to read as 
``Establishment registration and blood product listing requirements for 
foreign blood product establishments.''
    Proposed Sec. 607.40(b) would enable FDA to prohibit the 
importation of blood products from unregistered foreign establishments, 
in addition to prohibiting the importation of unlisted blood products. 
This prohibition would be similar to proposed Sec. 207.40(b) because 
blood and blood products are ``drugs'' within the meaning of section 
201(g) of the act. As stated earlier, the prohibition is consistent 
with sections 301(p), 501(a), and 801(a) of the act because, if a 
foreign establishment fails to register, FDA will be unable to 
determine, through an establishment inspection, whether that foreign 
establishment meets CGMP. Consequently, blood and blood products from 
those establishments would appear to be adulterated under section 
801(a)(3) of the act. Therefore, to enforce sections 301(p), 501(a), 
and 801(a) of the act effectively, in conjunction with section 510(i) 
of the act as it pertains to foreign establishment registration, 
proposed Sec. 607.40(b) would prohibit the importation of blood 
products that are not manufactured, prepared, propagated, compounded, 
or processed at a registered foreign establishment.
    Proposed Sec. 607.40(b) would also add establishment registration 
information to types of information that must be submitted in the 
English language.
    Proposed Sec. 607.40(c) would require foreign blood product 
establishments to submit the name and address of the establishment and 
the name of the individual responsible for submitting the establishment 
registration and product listing information as part of the 
establishment registration and blood product listing. Proposed 
Sec. 607.40(c) would also require foreign establishments to report any 
changes in their registration or listing information.
    Proposed Sec. 607.40(d) would require each foreign blood product 
establishment to submit the name, address, and phone number of its 
United States agent as part of its initial and updated registration 
information. Each foreign blood product establishment would be 
permitted to designate only one United States agent. Similar to 
proposed Sec. 207.40(c), proposed Sec. 607.40(d) would require the 
United States agent to reside or maintain a place of business in the 
United States, and, upon request from FDA, assist FDA in communications 
with the foreign establishment, respond to questions concerning 
imported products, and assist FDA in scheduling inspections. Proposed 
Sec. 607.40(d) would also enable FDA, when it is unable to contact the 
foreign manufacturer directly or expeditiously, to provide information 
or documents to the United States agent and for that act to be 
considered equivalent to providing the same information or documents to 
the foreign establishment. Changes to the United States agent's name, 
address, or phone number would, under proposed Sec. 607.40(d), be 
reported to FDA within 5 days of the change.

[[Page 26336]]

11. Section 607.65--Exemptions for Blood Product Establishments
    Section 607.65 lists several classes of persons who are exempt from 
registration and blood product listing under part 607. These 
exemptions, which currently pertain only to domestic establishments, 
reflect the statutory exemptions in section 510(g) of the act or 
represent a finding by the agency that registration of such persons is 
not necessary for the protection of the public health. For example, 
Sec. 607.65(c) exempts persons who manufacture blood products solely 
for use in research, teaching, or analysis. This exemption is 
consistent with section 510(g)(3) of the act. Section 607.65(d) exempts 
carriers who receive, carry, hold, or deliver blood products in their 
usual course of business, while Sec. 607.65(e) exempts persons who 
engage solely in the manufacture of in vitro diagnostic blood products 
and reagents that are not subject to licensing under section 351 of the 
Public Health Service Act (42 U.S.C. 262). FDA created the exemption in 
Sec. 607.65(d) because registering these persons was not necessary to 
protect the public health, whereas the exemption in Sec. 607.65(e) 
exists because nonlicensed, in vitro diagnostic establishments are 
subject to registration under part 807 instead of part 607.
    The proposed rule would amend Sec. 607.65 so that paragraphs (c), 
(d), and (e) would apply to both foreign and domestic persons or 
establishments. Foreign persons or establishments would not be included 
in the remaining exemptions in Sec. 607.65 because those exemptions 
depend on compliance with Federal, State, or local laws in the United 
States and its territories and because FDA has insufficient information 
to make a finding, under section 510(g)(5) of the act, that 
registration by such foreign establishments is not necessary to protect 
the public health. For example, Sec. 607.65(a) pertains to pharmacies 
operating under applicable local laws, while Sec. 607.65(b) pertains to 
practitioners licensed by law. Notwithstanding the proposed rule's 
limitation of these exemptions to pharmacies and practitioners in the 
United States and its territories, few foreign pharmacies or foreign 
practitioners are expected to be importing or offering for import blood 
and blood products into the United States, so they would not be subject 
to the foreign establishment registration requirement. As with the 
similar requirement in proposed Sec. 207.10, those that do import or 
offer to import such products to the United States should register to 
allow FDA to carry out its oversight responsibilities in this area. 
Similarly, Sec. 607.65(f) (transfusion services that are part of a 
facility approved for Medicare reimbursement) and Sec. 607.65(g) 
(clinical laboratories approved for Medicare reimbursement) both 
involve establishments approved for Medicare reimbursement; the agency 
does not anticipate that many foreign establishments are approved for 
Medicare reimbursement. Consequently, FDA is not proposing to extend 
these exemptions to foreign establishments and does not anticipate that 
many foreign transfusion services or clinical laboratories will be 
subject to the statutory registration requirement.

C. Proposed Changes to Part 807 (Devices)

1. Section 807.3--Definitions
    a. Definition of ``commercial distribution''. Section 807.3(b) 
currently defines ``commercial distribution,'' in part, as ``any 
distribution of a device intended for human use which is held or 
offered for sale * * *.''
    Similar to the proposed changes to Secs. 207.3 and 607.3, the 
proposed rule would create a new Sec. 807.3(b)(4) to state that, for 
foreign establishments, commercial distribution does not include 
distribution of a device that is neither imported nor offered for 
import into the United States.
    b. Definition of ``United States agent''. Currently, Sec. 807.3(r) 
defines a ``U.S.-designated agent'' as a person, residing in the United 
States, who is ``designated and authorized by the owner or operator of 
a foreign manufacturer who exports devices into the United States'' and 
who is responsible for submitting medical device reports and annual 
certifications, acting as the official correspondent, and submitting 
registration and listing information and premarket notifications. In 
the Federal Register of July 23, 1996 (61 FR 38345), FDA stayed the 
effective date for this and other provisions in part 807 (and 
elsewhere) that mention a U.S.-designated agent.
    The proposed rule would revise Sec. 807.3(r) to define a ``United 
States agent'' as ``any person residing or maintaining a place of 
business in the United States whom a foreign establishment designates 
as its agent.'' As stated earlier, FDA interprets the statutory 
requirement of a United States agent as allowing for only one United 
States agent for each foreign establishment and providing a foreign 
establishment the discretion to choose either an individual person or 
entity to serve as its United States agent.
    Additionally, unlike the existing provision, proposed Sec. 807.3(r) 
would not prescribe any duties for the United States agent. Proposed 
Sec. 807.40 would describe the United States agent's responsibilities 
and is discussed later in this document.
2. Section 807.20--Who Must Register and Submit a Device List
    Section 807.20(a) currently requires an ``owner or operator of an 
establishment not exempt under section 510(g) of the act'' or subpart D 
of part 807 who is engaged in the manufacture, preparation, 
propagation, compounding, assembly, or processing of a device intended 
for human use to register and to submit listing information. It also 
states that an owner or operator shall register and list devices 
``whether or not the output of the establishments or any particular 
device so listed enters interstate commerce.'' Section 807.20 also 
lists persons who are subject to the registration and listing 
requirements; one paragraph, at Sec. 807.20(a)(6), refers to persons 
who act as the ``U.S.-designated agent.''
    The proposal would amend Sec. 807.20(a) to clarify that an owner or 
operator ``shall'' register and list (unless it is otherwise exempt 
from such requirements). The proposal would also clarify that the 
language requiring owners and operators to register their 
establishments and to list devices, even if the devices do not enter 
interstate commerce, applies only to domestic firms. FDA is proposing 
this change because the agency has no intent to require foreign 
establishments to list devices that are not imported or offered for 
import into the United States, consistent with the language in section 
510(i)(1) of the act.
    The proposal would also amend the heading of subpart B, 
``Procedures for Domestic Device Establishments,'' to remove the word 
``domestic.'' This would reflect the fact that the act's registration 
and listing requirements now apply both to domestic establishments and 
to foreign establishments whose devices are imported or offered for 
import into the United States.
    The proposal would also delete Sec. 807.20(a)(6) pertaining to 
persons acting as the U.S.-designated agent. This deletion would 
complement changes to Secs. 807.3 and 807.40 (discussed below) which 
would give a foreign establishment discretion in defining most 
responsibilities of its United States agent.

[[Page 26337]]

3. Section 807.25--Information Required or Requested for Establishment 
Registration and Device Listing
    Section 807.25 currently states that FDA Forms FD-2891 and 2891(a) 
are the approved forms for establishment registration and device 
listing and that the required information includes ``post office ZIP 
Code.''
    The proposal would change this to read as ``post office code'' 
because the term ``ZIP Code'' is not used in many foreign countries.
4. Section 807.40--Establishment Registration and Device Listing for 
U.S. Agents of Foreign Establishments
    Currently, Sec. 807.40 requires foreign device manufacturers who 
export devices to the United States to designate a person as a ``U.S.-
designated agent.'' The U.S.-designated agent is responsible for duties 
such as submitting medical device reports, submitting annual 
certifications, acting as the manufacturer's official correspondent, 
and submitting registration and listing information and premarket 
notifications. The rule also directs foreign manufacturers to provide a 
statement of authorization for the U.S.-designated agent to FDA. 
However, in the Federal Register of July 23, 1996 (61 FR 38345), FDA 
stayed the effective date of this provision.
    The proposal would delete the existing language in Sec. 807.40 
entirely and replace it with general descriptions of the foreign 
establishment's obligations and the United States agent's role. The 
proposal would also use the term ``foreign establishment,'' rather than 
``foreign manufacturer,'' and revise the heading of Sec. 807.40 to be 
more consistent with section 510 of the act.
    Proposed Sec. 807.40(a) would require any foreign establishment 
engaged in the manufacture, preparation, propagation, compounding, or 
processing of a device that is imported or offered for import into the 
United States to register and list its devices in conformance with 
subpart B (``Procedures for Device Establishments''). This would have 
foreign establishments comply with the same procedures as domestic 
establishments.
    The proposal would also require the official correspondent for the 
foreign establishment to facilitate communication between the 
establishment's management and FDA. This change complements the 
requirement for an official correspondent in Sec. 807.25(d).
    Proposed Sec. 807.40(b) would require each registered foreign 
establishment to submit the name, address, and phone number of its 
United States agent as part of its registration information. Under the 
proposal, each foreign establishment would be able to designate only 
one United States agent. The proposal would also require the agent to 
reside or maintain a place of business in the United States, but would 
allow (rather than require) a foreign establishment to designate its 
United States agent as its official correspondent. Designating the 
United States agent as the official correspondent may be more efficient 
than having a separate United States agent and an official 
correspondent, but the proposed rule would give foreign establishments 
flexibility in deciding how to allocate their resources in this area 
and what the United States agent's responsibilities would be.
    FDA notes that electronic product manufacturers, under Sec. 1005.25 
(21 CFR 1005.25), must designate a permanent resident of the United 
States as the manufacturer's agent upon whom service of process may be 
made for and on behalf of the manufacturer as provided in section 
360(d) of the Radiation Control for Health and Safety Act of 1968. 
Manufacturers of products that are both medical devices and electronic 
products, therefore, may wish to consider whether their agents, under 
Sec. 1005.25, can also serve as their United States agent under 
proposed Sec. 807.40 and perform the duties expected of a United States 
agent.
    Like proposed Secs. 207.40 and 607.40, proposed Sec. 807.40(b) also 
would require the United States agent, upon request from FDA, to assist 
the agency in communications with the foreign establishment, to respond 
to questions regarding devices imported or offered for import, and to 
assist FDA in scheduling inspections of the foreign establishment. 
Proposed Sec. 807.40(b) would also enable FDA, when it is unable to 
contact the foreign manufacturer directly or expeditiously, to provide 
information or documents to the United States agent and for that act to 
be considered equivalent to providing the same information or documents 
to the foreign establishment, and would further require a foreign 
establishment to report to FDA changes in the United States agent's 
name, address, or phone number within 5 days of the change.
    Proposed Sec. 807.40(c), like proposed Secs. 207.40(b) and 
607.40(b), would prohibit the importation of devices that have not been 
listed or manufactured, prepared, propagated, compounded, or processed 
at a registered foreign establishment. This provision is consistent 
with the act in several respects. Under section 502(o) of the act, a 
device that is not included in a list is misbranded, and section 
801(a)(3) of the act authorizes FDA to refuse admission of misbranded 
articles. Additionally, prohibiting imports from unregistered foreign 
establishments is consistent with sections 301(p), 501(h), and 801(a) 
of the act because, if a foreign establishment fails to register, FDA 
will be unable to determine whether that foreign establishment meets 
the requirements of the CGMP/quality systems regulation. (Section 
501(h) of the act considers a device to be adulterated if the device 
and the methods used in, or the facilities or controls used for, the 
device's manufacture, packing, storage, or installation are not in 
conformity with CGMP.) Consequently, to enforce sections 301(p), 
501(h), and 801(a) of the act effectively, in conjunction with section 
510(i) of the act as it pertains to foreign establishment registration, 
proposed Sec. 807.40(c) would prohibit the importation of devices that 
are not manufactured, prepared, propagated, compounded, or processed at 
a registered foreign establishment. Such a requirement is therefore 
authorized under section 701(a) of the act for the efficient 
enforcement of the act.

D. Other Rules Affecting Establishment Registration and Listing

    The proposed rule would also revise the authority citations for 
parts 207 and 807 to be consistent with other regulations published by 
the agency in the Federal Register of May 13, 1998 (63 FR 26690) and 
May 14, 1998 (63 FR 26744). The former would amend various FDA 
regulations to delete references to the certification of insulin and to 
section 506 of the act (which was repealed by FDAMA), while the latter 
would require establishment registration and listing for manufacturers 
of human cellular and tissue-based products.
    The proposal would also add sections 201, 801, and 903 of the act 
(21 U.S.C. 393) to the authority citation for parts 207, 607, and 807. 
Section 201 of the act contains definitions, such as the definition of 
a ``State,'' and some definitions are relevant to these regulations. 
Section 801 of the act provides authority over imports, whereas section 
903 of the act establishes, among other things, FDA's mission and 
interagency collaboration obligations.
    The proposal would further revise the authority citation for part 
607 by deleting the citation for 42 U.S.C. 216, and adding 42 U.S.C. 
264 and 271. The former provision concerns regulatory authority 
relating to commissioned corps members and is therefore

[[Page 26338]]

inapplicable to part 607, whereas the latter provisions provide 
authority to issue regulations to control communicable disease and 
establish penalties for violation of quarantine laws.

E. Registration Schedules

    Because part 207 applies to human drugs, animal drugs, and some 
biologics, FDA intends to develop a staggered schedule for foreign 
establishment registration. In general, the registration schedule would 
be similar in concept to Sec. 207.21 whereby firms whose name began 
with a particular letter of the alphabet would register within a 
specific month. For example, a firm whose name began with the letter 
``a'' or ``b'' might be requested to register by January, whereas a 
firm whose name began with the letter ``c'' might be requested to 
register by February. The precise dates, however, may depend upon the 
date on which FDA publishes a final rule in the Federal Register. 
Therefore, FDA intends to announce the schedule for foreign 
establishment registration for firms subject to part 207 in the 
preamble to the final rule.
    Comparatively fewer foreign manufacturers are subject to the 
registration requirements in parts 607 and 807. Consequently, the 
agency does not intend to develop any special registration schedules 
for parts 607 and 807.

III. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the principles set out in the 
Executive Order. In addition, the proposed rule is a significant 
regulatory action as defined in Executive Order 12866.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. FDA believes that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities, but has conducted an initial regulatory flexibility analysis 
to ensure that impacts on small entities were assessed and to alert any 
potentially impacted small entities to the opportunity to submit 
comments to FDA.
    The proposed rule would require foreign establishments that import 
or offer for import human drugs, animal drugs, biologics, blood, blood 
products, and devices into the United States to register and to 
identify a United States agent. Before FDAMA amended section 510 of the 
act to require foreign establishment registration, many foreign 
establishments voluntarily registered their establishments, but all 
foreign establishments that imported or offered for import drugs, blood 
and blood products, and devices into the United States were required to 
list their products. The registration and listing activities used forms 
prepared by FDA. (FDA plans to revise these forms in the future to 
provide for the identification of a United States agent by foreign 
establishments.)
    Because foreign establishments were (and still are) required to 
list their products, FDA can estimate the number of foreign 
establishments that would be required to register under the proposed 
rule. However, because all of these establishments are outside the 
United States, FDA is unable to estimate accurately the number of 
foreign establishments that would be considered small entities and the 
extent to which these foreign establishments conduct business in the 
United States.
    Nevertheless, FDA is able to estimate the proposed rule's economic 
impact by using time and cost estimates for registration. FDA estimates 
the costs associated with establishment registration are small, ranging 
from $20 per hour for device establishments, $25 per hour for blood and 
blood product establishments, and $100 per hour for drug 
establishments. These costs are based on information obtained primarily 
from domestic establishments, and FDA is assuming that the average 
costs for foreign establishments will be similar. FDA also estimates 
that completing an establishment registration form will range from 15 
minutes to 1 hour (depending on the form used). These estimates are 
derived from the estimated registration costs for domestic 
establishments and foreign establishments that voluntarily registered 
before FDAMA's enactment. Thus, the proposed rule, if finalized, should 
not have a significant economic impact on a substantial number of small 
entities.
    The agency examined, but rejected, alternatives to the proposed 
rule. The registration information required by FDA in the proposal is 
minimal, consisting largely of the establishment's address, names of 
owners or responsible officials, and additional identifying information 
on the establishment (such as type of establishment, types of products 
at the establishment, type of ownership). Similarly, identification of 
the United States agent would require minimal information (name, 
address, phone number). An alternative that required less information 
from foreign establishments would not provide sufficient information to 
identify the foreign establishment's location, a responsible person at 
the foreign establishment, or the type of establishment, thereby 
complicating any effort to locate or contact the foreign establishment 
or to determine whether the foreign establishment complied with the 
appropriate statutory and regulatory requirements. An alternative that 
required less frequent reporting by foreign establishments was rejected 
because it would increase the likelihood that the information possessed 
by FDA would be incorrect or obsolete and hinder the conduct of 
regulatory actions involving foreign establishments.
    The Unfunded Mandates Reform Act (Pub. L. 104-114) requires that 
agencies prepare an assessment of anticipated costs and benefits before 
proposing any rule that may result in an expenditure in any 1 year by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation). FDA estimates that the reporting costs for industry under 
the proposed rule would total $809,820. This estimate is based on 
annual projections of 4,160.5 hours for drug industry reports, 108.5 
hours for blood and blood product reports, and 15,664 hours for device 
reports, multiplied by hourly industry costs of $100, $20, and $25 per 
report respectively. The estimated recordkeeping cost to industry is 
$810,000, based on an estimated 32,400 records at $25 per hour. Thus, 
because the total expenditures under the proposal will not result in a 
1-year expenditure of $100 million or more, FDA is not required to 
perform a cost-benefit analysis under the Unfunded Mandates Reform Act.

IV. Environmental Impact

    The agency has determined, under 21 CFR 25.30(h), that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

[[Page 26339]]

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to public comment and review by OMB under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, 
and respondent description for the information collection requirements 
are shown below with an estimate of the annual reporting and 
recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Foreign Establishment Registration and Listing.
    Description: The proposed rule would require foreign establishments 
that import or offer to import human drugs, animal drugs, biologics, 
blood products, and devices into the United States to register and to 
name a United States agent. This information is required by section 
510(i)(1) of the act, as amended by section 417 of FDAMA.
    Although section 510(i)(2) of the act also requires foreign 
establishments to list their products at FDA, the proposed rule does 
not include such a requirement because FDA's existing regulations 
already require foreign manufacturers to submit such lists, and the 
agency has already obtained OMB approval for the information collection 
burden associated with product listing for parts 207 and 607 (for part 
207, the OMB approval number is 0910-0045 and expires on April 30, 
2001; for part 607, the OMB approval number is 0910-0052 and expires on 
April 30, 2000). Through this notice, FDA is also seeking approval for 
the device listing requirements insofar as they will be applied to 
foreign establishments.
    Description of Respondents: Persons and businesses, including small 
businesses.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                      No. of
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
----------------------------------------------------------------------------------------------------------------
207.21(a)                           2,463               1           2,463               0.5         1,231.5
207.22(a) and 207.40                5,630               1           5,630               0.5         2,815
207.25(b)                              53               4.8           228               0.5           114
607.22(a) and 607.40                   98               1              98               1              98
607.26                                  1               1               1               0.5             0.5
607.31                                  1               1               1              10              10
807.22(a) and 807.40                7,200               1           7,200               0.25        1,800
807.22(b)                          27,720               1          27,720               0.5        13,860
807.31(e)                               7               1               7               0.5             4
Total                                                                                              19,933
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
                                                  No. of Records
         21 CFR Section               No. of            per        Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeper       Records         Record
----------------------------------------------------------------------------------------------------------------
807.31                              6,480              10          64,800               0.5        32,400
Total                                                                                              32,400
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In general, FDA based the above estimates on the number of foreign 
establishments that currently list drugs, blood products, or devices 
(as required by existing FDA regulations) and on comparable burden hour 
estimates for registration by domestic establishments. Accordingly, 
FDA's estimate of 30 minutes for each initial drug report 
(Sec. 207.22), 1 hour for each initial biologic report (Sec. 607.22), 
45 minutes for each device report (Sec. 807.22), and 30 minutes for 
each additional report submitted (Sec. 807.31) is consistent with 
current practices.
    For proposed Secs. 207.21(a) and 207.25(b), the agency estimated 
the number of respondents submitting ANDA's or ANADA's from the number 
of establishments submitting listing information. For proposed 
Sec. 207.21(a), FDA's drug listing records indicate that there are 
2,410 firms submitting ANDA's and 53 firms submitting ANADA's, for a 
total of 2,463 respondents. The proposed rule would amend 
Sec. 207.25(b) to include ANADA's, and FDA records indicate that 228 
ANADA's were submitted; consequently, the total number of respondents 
is 53, with a total of 228 annual responses. The estimated total annual 
responses and hours per response are consistent with existing figures 
for other establishments subject to Secs. 207.21 and 207.25.
    For proposed Secs. 607.26 and 607.31, FDA's experience reveals that 
only one establishment has reported information under these provisions 
in recent years. Therefore, the agency assigned an estimate of one 
respondent for each provision. The agency estimated the burden hours 
for these provisions by examining their complexity. Because proposed 
Sec. 607.26 would require reporting changes in individual

[[Page 26340]]

ownership, corporate or partnership structure, location, or blood-
product handling activity, the agency assigned 30 minutes as the 
reporting burden. In contrast, Sec. 607.31 authorizes the agency to 
request additional information by letter. FDA has made no requests in 
recent years, but has assigned 10 hours as a reporting burden for this 
provision.
    The estimated recordkeeping burden for proposed Sec. 807.31 is 
based on FDA's experience with foreign device establishments. FDA's 
experience indicates that there are approximately 9 owners or operators 
for every 10 foreign device establishments. Consequently, the estimated 
number of recordkeepers is 6,480 (7,200 x 0.9 = 6,480), and the average 
frequency and average burden per record, based on comparable figures 
for domestic establishments, are 10 and 30 minutes respectively. This 
results in a total recordkeeping burden of 32,400 hours (6,480 
recordkeepers x 10 records per recordkeeper x 0.5 hours per record = 
32,400 hours).
    In compliance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information 
collection requirements of this proposed rule to OMB for review. 
Interested persons are requested to send comments regarding information 
collection by June 14, 1999, to the Office of Information and 
Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., 
Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.

List of Subjects

21 CFR Part 207

    Drugs, Reporting and recordkeeping requirements.

21 CFR Part 607

    Blood.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 207, 607, and 807 be amended as follows:

PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS 
IN COMMERCIAL DISTRIBUTION

    1. The authority citation for part 21 CFR part 207 is revised to 
read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 
374, 381, 393; 42 U.S.C. 262, 264, 271.

    2. Section 207.3 is amended by revising paragraph (a)(5) and by 
adding paragraph (a)(11) to read as follows:


Sec. 207.3  Definitions.

    (a) * * *
    (5) Commercial distribution means any distribution of a human drug 
except for investigational use under part 312 of this chapter, and any 
distribution of an animal drug or animal feed bearing or containing an 
animal drug for noninvestigational uses, but the term does not include 
internal or interplant transfer of a bulk drug substance between 
registered establishments within the same parent, subsidiary, and/or 
affiliate company. For foreign establishments, the term ``commercial 
distribution'' shall have the same meaning except that the term shall 
not include distribution of any drug that is neither imported nor 
offered for import into the United States.
* * * * *
    (11) United States agent means a person residing or maintaining a 
place of business in the United States whom a foreign establishment 
designates as its agent.
* * * * *
    3. Section 207.7 is amended by revising paragraph (a) to read as 
follows:


Sec. 207.7  Establishment registration and product listing for human 
blood and blood products and for medical devices.

    (a) Owners and operators of human blood and blood product 
establishments shall register and list their products with the Center 
for Biologics Evaluation and Research (HFM-375), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, on Form FDA-2830 (Blood Establishment Registration and Product 
Listing), in accordance with part 607 of this chapter. Such owners and 
operators who also manufacture or process other drug products at the 
same establishment shall, in addition, register and list all such other 
drug products with the Drug Listing Branch in accordance with this 
part.
* * * * *
    4. Section 207.10 is amended by revising the section heading and 
the introductory text to read as follows:


Sec. 207.10  Exemptions for establishments.

    The following classes of persons are exempt from registration and 
drug listing in accordance with this part under section 510(g)(1), 
(g)(2), and (g)(3) of the act, or because FDA has found, under section 
510(g)(5), that their registration is not necessary for the protection 
of the public health. The exemptions in paragraphs (a) and (b) of this 
section are limited to pharmacies, hospitals, clinics, and public 
health agencies located in any State as defined in section 201(a)(1) of 
the act.
* * * * *
    5. Section 207.20 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec. 207.20  Who must register and submit a drug list.

    (a) Owners or operators of all drug establishments, not exempt 
under section 510(g) of the act or subpart B of this part 207, that 
engage in the manufacture, preparation, propagation, compounding, or 
processing of a drug or drugs shall register and submit a list of every 
drug in commercial distribution (except that listing information may be 
submitted by the parent, subsidiary, and/or affiliate company for all 
establishments when operations are conducted at more than one 
establishment and there exists joint ownership and control among all 
the establishments). Drug listing is not required for the 
manufacturing, preparation, propagation, compounding, or processing of 
an animal feed bearing or containing an animal drug (i.e., a Type B or 
Type C medicated feed), nor is drug listing required for establishments 
engaged in drug product salvaging. Drug products manufactured, 
prepared, propagated, compounded, or processed in any State as defined 
in section 201(a)(1) of the act must be listed whether or not the 
output of such establishments or any particular drug so listed enters 
interstate commerce. No owner or operator may register an establishment 
if any part of the establishment is registered by any other owner or 
operator.
* * * * *
    (c) Before beginning manufacture or processing of a drug subject to 
one of the following applications, an owner or operator of an 
establishment is required to register before the agency approves it: A 
new drug application, an abbreviated new drug application, a new animal 
drug application, an abbreviated new animal drug application, a 
medicated feed application, or a biologics license application.
* * * * *


Sec. 207.21  [Amended]

    6. Section 207.21 Times for registration and drug listing is 
amended in the second sentence of paragraph (a) by adding the phrase 
``abbreviated new drug application,'' after the phrase ``new drug 
application,'' and by adding the

[[Page 26341]]

phrase ``abbreviated new animal drug application,'' after the phrase 
``new animal drug application,''.


Sec. 207.25  [Amended]

    7. Section 207.25 Information required in registration and drug 
listing is amended in paragraph (b)(2) by adding the phrase 
``abbreviated new animal drug application number,'' after the phrase 
``new animal drug application number,''.
    8. Section 207.37 is amended by revising the introductory text of 
paragraph (a) and by revising paragraph (b) to read as follows:


Sec. 207.37  Inspection of registrations and drug listings.

    (a) A copy of the Form FDA-2656 (Registration of Drug 
Establishment) filed by the registrant will be available for inspection 
in accordance with section 510(f) of the act, at the Division of 
Labeling and Non-Prescription Drug Compliance (HFD-310), Office of 
Compliance, Center for Drug Evaluation and Research, Food and Drug 
Administration, 7520 Standish Pl., Rockville, MD 20855. In addition, 
copies of these forms for establishments located within a particular 
geographic area are available for inspection at FDA district offices 
responsible for that geographical area. Copies of forms submitted by 
foreign drug establishments are available for inspection at the Foreign 
Inspection Team (HFD-322), Office of Compliance, Center for Drug 
Evaluation and Research, Food and Drug Administration, 7520 Standish 
Pl., Rockville, MD 20855. Upon request and receipt of a stamped, self-
addressed envelope, the Division of Labeling and Non-Prescription Drug 
Compliance, the Foreign Inspection Team, or the appropriate FDA 
district office will verify registration numbers or provide the 
location of a registered establishment.
* * * * *
    (b) Requests for information about registrations and drug listings 
of an establishment should be directed to the Information Management 
Team (HFD-095), Office of Information Technology, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857 or, with respect to the information described 
in paragraph (a) of this section, to the FDA district office 
responsible for the geographic area in which the establishment is 
located.
    9. Section 207.40 is revised to read as follows:


Sec. 207.40  Establishment registration and drug listing requirements 
for foreign drug establishments.

    (a) Foreign drug establishments whose drugs are imported or offered 
for import into the United States shall comply with the establishment 
registration and drug listing requirements in subpart C of this part, 
unless exempt under subpart B of this part.
    (b) No drug, unless it is listed as required in subpart C of this 
part and manufactured, prepared, propagated, compounded, or processed 
at a registered foreign drug establishment, may be imported or offered 
for import into the United States except a drug imported or offered for 
import under the investigational use provisions in part 312 of this 
chapter. Foreign drug establishments shall submit all listing 
information, including labels and labeling, and registration 
information in the English language.
    (c) Each foreign drug establishment required to register under 
paragraph (a) of this section shall submit the name, address, and phone 
number of its United States agent as part of its initial and updated 
registration information in accordance with subpart C of this part. 
Each foreign drug establishment shall designate only one United States 
agent.
    (1) The United States agent shall reside or maintain a place of 
business in the United States.
    (2) Upon request from FDA, the United States agent shall assist FDA 
in communications with the foreign drug establishment, respond to 
questions concerning the foreign drug establishment's products that are 
imported or offered for import into the United States, and assist FDA 
in scheduling inspections of the foreign drug establishment. If the 
agency is unable to contact the foreign drug establishment directly or 
expeditiously, FDA may provide information or documents to the United 
States agent, and such an action shall be considered to be equivalent 
to providing the same information or documents to the foreign drug 
establishment.
    (3) The foreign drug establishment shall report changes in the 
United States agent's name, address, or phone number to FDA within 5 
days of the change.

PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR 
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS

    10. The authority citation for 21 CFR part 607 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 
381, 393; 42 U.S.C. 262, 264, 271.

    11. Section 607.3 is amended by revising paragraph (e) and by 
adding paragraph (j) to read as follows:


Sec. 607.3  Definitions.

* * * * *
    (e) Commercial distribution means any distribution of a blood 
product except pursuant to the investigational use provisions of part 
312 of this chapter, but does not include internal or interplant 
transfer of a bulk product substance between registered establishments 
within the same parent, subsidiary, and/or affiliate company. For 
foreign establishments, the term ``commercial distribution'' shall have 
the same meaning except that the term shall not include distribution of 
any blood or blood product that is neither imported nor offered for 
import into the United States.
* * * * *
    (j) United States agent means a person residing or maintaining a 
place of business in the United States whom a foreign establishment 
designates as its agent.
    12. Section 607.7 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec. 607.7  Establishment registration and product listing of blood 
banks and other firms manufacturing human blood and blood products.

* * * * *
    (b) Forms for registration of an establishment are obtainable on 
request from the Center for Biologics Evaluation and Research (HFM-
375), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, or at any of the Food and Drug Administration 
district offices.
    (c) The completed form should be mailed to the Center for Biologics 
Evaluation and Research (HFM-375), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
    13. Section 607.20 is amended by revising paragraph (a) to read as 
follows:


Sec. 607.20  Who must register and submit a blood product list.

    (a) Owners or operators of all establishments, not exempt under 
section 510(g) of the act or subpart D of this part 607, that engage in 
the manufacture of blood products shall register and submit a list of 
every blood product in commercial distribution (except that listing 
information may be submitted by the parent, subsidiary, and/or 
affiliate company for all establishments when operations are conducted 
at more than one establishment and there exists joint

[[Page 26342]]

ownership and control among all the establishments). Blood products 
manufactured, prepared, propagated, compounded, or processed in any 
State as defined in section 201(a)(1) of the act must be listed whether 
or not the output of such blood product establishment or any particular 
blood product so listed enters interstate commerce.
* * * * *
    14. Section 607.22 is revised to read as follows:


Sec. 607.22  How and where to register establishments and list blood 
products.

    (a) The first registration of an establishment shall be on Form FD-
2830 (Blood Establishment Registration and Product Listing) obtainable 
on request from the Center for Biologics Evaluation and Research (HFM-
375), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, or from Food and Drug Administration district 
offices. Subsequent annual registration shall also be accomplished on 
Form FD-2830 which will be furnished by the Food and Drug 
Administration before November 15 of each year to establishments whose 
product registration for that year was validated pursuant to 
Sec. 607.35. The completed form shall be mailed to the above address 
before December 31 of that year.
    (b) The first list of blood products and subsequent June and 
December updatings shall be on Form FD-2830, obtainable upon request as 
described in paragraph (a) of this section.


Sec. 607.25  [Amended]

    15. Section 607.25 Information required for establishment 
registration and blood product listing is amended in the second 
sentence of paragraph (a) by removing the word ``ZIP''.
    16. Section 607.26 is amended by revising the first sentence to 
read as follows:


Sec. 607.26  Amendments to establishment registration.

    Changes in individual ownership, corporate or partnership 
structure, location, or blood-product handling activity shall be 
submitted on Form FD-2830 (Blood Establishment Registration and Product 
Listing) as an amendment to registration within 5 days of such changes. 
* * *
    17. Section 607.31 is amended by revising paragraph (a) and by 
removing and reserving paragraph (b) to read as follows:


Sec. 607.31  Additional blood product listing information.

    (a) In addition to the information routinely required by 
Secs. 607.25 and 607.30, the Director of the Center for Biologics 
Evaluation and Research may require submission of the following 
information by letter or by Federal Register notice:
    (1) For a particular blood product so listed, upon request made by 
the Director of the Center for Biologics Evaluation and Research for 
good cause, a copy of all advertisements.
    (2) For a particular blood product so listed, upon a finding by the 
Director of the Center for Biologics Evaluation and Research that it is 
necessary to carry out the purposes of the act, a quantitative listing 
of all ingredients.
    (3) For each registrant, upon a finding by the Director of the 
Center for Biologics Evaluation and Research that it is necessary to 
carry out the purposes of the act, a list of each listed blood product 
containing a particular ingredient.
    (b) [Reserved]
    18. Section 607.35 is amended by revising paragraph (a) to read as 
follows:


Sec. 607.35  Notification of registrant; blood product establishment 
registration number and NDC Labeler Code

    (a) The Director of the Center for Biologics Evaluation and 
Research will provide to the registrant a validated copy of Form FD-
2830 (Blood Establishment Registration and Product Listing) as evidence 
of registration. This validated copy will be sent to the location shown 
for the registering establishment, and a copy will be sent to the 
reporting official if at another address. A permanent registration 
number will be assigned to each blood product establishment registered 
in accordance with the regulations of this subpart.
* * * * *
    19. Section 607.37 is amended by revising the introductory text of 
paragraph (a) and by revising paragraph (b) to read as follows:


Sec. 607.37  Inspection of establishment registrations and blood 
product listings.

    (a) A copy of the Form FD-2830 (Blood Establishment Registration 
and Product Listing) filed by the registrant will be available for 
inspection pursuant to section 510(f) of the act, at the Office of 
Communication, Training and Manufacturers' Assistance (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. In addition, 
for domestic firms, the same information will be available for 
inspection at each of the Food and Drug Administration district offices 
for firms within the geographical area of such district office. Upon 
request and receipt of a self-addressed stamped envelope, verification 
of registration number, or location of registered establishment will be 
provided. The following information submitted pursuant to the blood 
product listing requirements is illustrative of the type of information 
that will be available for public disclosure when it is compiled:
* * * * *
    (b) Requests for information regarding blood establishment 
registrations and blood product listings should be directed to the 
Office of Communication, Training and Manufacturers' Assistance (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448.
    20. Section 607.40 is revised to read as follows:


Sec. 607.40  Establishment registration and blood product listing 
requirements for foreign blood product establishments.

    (a) Every foreign establishment shall comply with the establishment 
registration and blood product listing requirements contained in 
subpart B of this part, unless exempt under subpart D of this part.
    (b) No blood product may be imported or offered for import into the 
United States except a blood product imported or offered for import 
pursuant to the investigational use provisions of part 312 of this 
chapter, unless it is the subject of a blood product listing as 
required under subpart B of this part and is manufactured, prepared, 
propagated, compounded, or processed at a registered foreign 
establishment. The establishment registration and blood product listing 
information shall be in the English language.
    (c) Each foreign establishment required to register under paragraph 
(a) of this section shall, as part of the establishment registration 
and blood product listing, submit the name and address of the 
establishment and the name of the individual responsible for submitting 
establishment registration and blood product listing information. Any 
changes in this information shall be reported to the Food and Drug 
Administration at the intervals specified for updating establishment 
registration information in Sec. 607.26 and blood product listing 
information in Sec. 607.30(a).
    (d) Each foreign establishment required to register under paragraph 
(a) of this section shall submit the name, address, and phone number of 
its United States agent as part of its initial and updated registration 
information in

[[Page 26343]]

accordance with subpart B of this part. Each foreign establishment 
shall designate only one United States agent.
    (1) The United States agent shall reside or maintain a place of 
business in the United States.
    (2) Upon request from FDA, the United States agent shall assist FDA 
in communications with the foreign establishment, respond to questions 
concerning the foreign establishment's products that are imported or 
offered for import into the United States, and assist FDA in scheduling 
inspections of the foreign establishment. If the agency is unable to 
contact the foreign establishment directly or expeditiously, FDA may 
provide information or documents to the United States agent, and such 
an action shall be considered to be equivalent to providing the same 
information or documents to the foreign establishment.
    (3) The foreign establishment shall report changes in the United 
States agent's name, address, or phone number to FDA within 5 days of 
the change.
    21. Section 607.65 is amended by revising the introductory text to 
read as follows:


Sec. 607.65  Exemptions for blood product establishments.

    The following classes of persons are exempt from registration and 
blood product listing in accordance with this part 607 under the 
provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or 
because the Commissioner has found, under section 510(g)(4), that such 
registration is not necessary for the protection of the public health. 
The exemptions in paragraphs (a), (b), (f), and (g) of this section are 
limited to those classes of persons located in any State as defined in 
section 201(a)(1) of the act.
* * * * *

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND DISTRIBUTORS OF DEVICES

    22. The authority citation for 21 CFR part 807 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

    23. Section 807.3 is amended by revising paragraphs (b) and (r) to 
read as follows:


Sec. 807.3  Definitions.

* * * * *
    (b) Commercial distribution means any distribution of a device 
intended for human use which is held or offered for sale but does not 
include the following:
    (1) Internal or interplant transfer of a device between 
establishments within the same parent, subsidiary, and/or affiliate 
company;
    (2) Any distribution of a device intended for human use which has 
in effect an approved exemption for investigational use pursuant to 
section 520(g) of the act and part 812 of this chapter;
    (3) Any distribution of a device, before the effective date of part 
812 of this chapter, that was not introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, and that is classified into class III under 
section 513(f) of the act: Provided, That the device is intended solely 
for investigational use, and under section 501(f)(2)(A) of the act the 
device is not required to have an approved premarket approval 
application as provided in section 515 of the act; or
    (4) For foreign establishments, the distribution of any device that 
is neither imported nor offered for import into the United States.
* * * * *
    (r) United States agent means a person residing or maintaining a 
place of business in the United States whom a foreign establishment 
designates as its agent.
* * * * *
    24. The heading to subpart B ``Procedures for Domestic Device 
Establishments'' is revised to read as follows:

Subpart B--Procedures for Device Establishments

    25. Section 807.20 is amended by revising paragraph (a) to read as 
follows:


Sec. 807.20  Who must register and submit a device list.

    (a) An owner or operator of an establishment not exempt under 
section 510(g) of the act or subpart D of this part who is engaged in 
the manufacture, preparation, propagation, compounding, assembly, or 
processing of a device intended for human use shall register and submit 
listing information for those devices in commercial distribution, 
except that listing information may be submitted by the parent, 
subsidiary, or affiliate company for all the domestic or foreign 
establishments under the control of one of these organizations when 
operations are conducted at more than one establishment and there 
exists joint ownership and control among all the establishments. The 
term ``device'' includes all in vitro diagnostic products and in vitro 
diagnostic biological products not subject to licensing under section 
351 of the Public Health Service Act. An owner or operator of an 
establishment located in any State as defined in section 201(a)(1) of 
the act shall register its name, places of business, and all 
establishments and list the devices whether or not the output of the 
establishments or any particular device so listed enters interstate 
commerce. The registration and listing requirements shall pertain to 
any person who:
    (1) Initiates or develops specifications for a device that is to be 
manufactured by a second party for commercial distribution by the 
person initiating specifications;
    (2) Manufactures for commercial distribution a device either for 
itself or for another person. However, a person who only manufactures 
devices according to another person's specifications, for commercial 
distribution by the person initiating specifications, is not required 
to list those devices;
    (3) Repackages or relabels a device;
    (4) Acts as an initial importer; or
    (5) Manufactures components or accessories which are ready to be 
used for any intended health-related purpose and are packaged or 
labeled for commercial distribution for such health-related purpose, 
e.g., blood filters, hemodialysis tubing, or devices which of necessity 
must be further processed by a licensed practitioner or other qualified 
person to meet the needs of a particular patient, e.g., a manufacturer 
of ophthalmic lens blanks.
* * * * *


Sec. 807.25  [Amended]

    26. Section 807.25 Information required or requested for 
establishment registration and device listing is amended in the last 
sentence of paragraph (a) by removing the word ``ZIP''.
    27. Section 807.40 is revised to read as follows:


Sec. 807.40  Establishment registration and device listing for foreign 
establishments importing or offering for import devices into the United 
States.

    (a) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
device that is imported or offered for import into the United States 
shall register and list such devices in conformance with the 
requirements in subpart B of this part. The official correspondent for 
the foreign establishment shall facilitate communication between the 
foreign establishment's management and

[[Page 26344]]

representatives of the Food and Drug Administration.
    (b) Each foreign establishment required to register under paragraph 
(a) of this section shall submit the name, address, and phone number of 
its United States agent as part of its initial and updated registration 
information in accordance with subpart B of this part. Each foreign 
establishment shall designate only one United States agent and may 
designate the United States agent to act as its official correspondent.
    (1) The United States agent shall reside or maintain a place of 
business in the United States.
    (2) Upon request from FDA, the United States agent shall assist FDA 
in communications with the foreign establishment, respond to questions 
concerning the foreign establishment's products that are imported or 
offered for import into the United States, and assist FDA in scheduling 
inspections of the foreign establishment. If the agency is unable to 
contact the foreign establishment directly or expeditiously, FDA may 
provide information or documents to the United States agent, and such 
an action shall be considered to be equivalent to providing the same 
information or documents to the foreign establishment.
    (3) The foreign establishment shall report changes in the United 
States agent's name, address, or phone number to FDA within 5 days of 
the change.
    (c) No device may be imported or offered for import into the United 
States except a device imported or offered for import pursuant to the 
investigational use provisions of part 812 of this chapter, unless it 
is the subject of a device listing as required under subpart B of this 
part and is manufactured, prepared, propagated, compounded, or 
processed at a registered foreign establishment. The establishment 
registration and device listing information shall be in the English 
language.

    Dated: January 26, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-12040 Filed 5-13-99; 8:45 am]
BILLING CODE 4160-01-F